Usability of Medical Applications Ved Line Kagenow Svenstrup,

Size: px
Start display at page:

Download "Usability of Medical Applications Ved Line Kagenow Svenstrup, lks@delta.dk"

Transcription

1 Usability of Medical Applications Ved Line Kagenow Svenstrup,

2 What is usability? The user, rather than the system, at the center of the process. Risk of operating errors that can cause injury is minimized as much as possible. Safe operating concept, which takes into account users' background/qualifications. Usability testing: users work and interact with the product interface and share their views and concerns. Usability is a measure of how easy it is to use a product to perform prescribed tasks. Characteristic of the user interface that establishes effectiveness, efficiency, ease of user learning and user satisfaction IEC 62366

3 WHY DO IT?

4 Interface Why do it? It s certainly possible to release a working, bug-free product without performing any usability work at all. Information Processing Use error Information Perception Use error User Use error Control actions Output Device/App Input Processing

5 Why do it? Prevent medical error! Avoid design shortcomings that lead to use error. One in three device incidents relate to use error (FDA). Many recalls of medical devices is due to bad product design. Increasing use of medical devices in patient homes Inexperienced users, other needs Clearer regulatory compliance Today requires both EU directives on medical devices and the U.S. Food and Drug Administration (FDA) that human factors and risks of use errors are treated in the development of medical devices.

6 Why do it? Usability can help differentiate your products from those of your competitors. Product with the the Core. Usability testing helps improve user acceptance User acceptance often directly correlates to repeat buying or to loyalty, which means the user is likely to recommend the product. Shorter time to market (by avoiding interface problems late in the development process). Time and resources saved in post release issues and dispensable documentation. Reduce the number of support calls from users. Reduce the need for information to be provided to the user.

7 LEGISLATION

8 Legal framework Directive 2007/47/EC, which revised MDD and AIMDD, clarifies/emphasises usability requirements (became effective on 21 March 2010) Essential requirement 1 of Annex 1 of MDD was revised to include two additions to requirement: to reduce, as much as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used to consider the technical knowledge, experience, education and training and, where applicable, the medical and physical conditions of intended users (design for lay, professional, disabled or other users).

9 Primary standards EU/US ISO/IEC 62366: Medical devices Application of usability engineering to medical devices Usability engineering process, Accompanying document, Training AAMI/ANSI HE75:2009 Human factors engineering Design of medical devices General considerations and principles (Managing the risk of use error, Usability testing), Design elements (Controls, Software), Integrated solutions (Mobile medical devices, Home health care) ANSI/AAMI/ISO 14971: Medical devices Application of risk management to medical devices Risk management, Risk analysis, Risk evaluation, Evaluation of overall residual risk acceptability IEC 62304: Medical device software Software life cycle processes Development, SW maintenance, SW risk management, SW configuration management, SW problem resolution)

10 Guidance documents issued by FDA Applying HF&UE to Optimize Medical Device Design (draft 2011) MedicalDevices/ DeviceRegulationand Guidance/ GuidanceDocuments/ ucm htm Medical Device Use Safety: Incorporating Human Factors Engineering into Risk Management MedicalDevices/ DeviceRegulationand Guidance/ GuidanceDocuments/ ucm htm General Principles of Software Validation (http://www.fda.gov/ MedicalDevices/DeviceRegulationand Guidance/ GuidanceDocuments/ ucm htm) Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (http://www.fda.gov/ MedicalDevices/ DeviceRegulationand Guidance/ GuidanceDocuments/ ucm htm)

11 HOW TO PRACTICE - WHERE DO USE ERRORS OCCUR?

12 Usability Design - Human Factors

13 Users The ability of a user to operate a medical device/app depends on his or her personal characteristics. Professional or non professional Job title and responsibilities Knowledge and experience levels Age and functional capabilities Physical, sensory/perceptual, cognitive/intellectual Mental and emotional condition

14 Use environment Use environments might be: Clinical environment (Hospital, clinic, etc.) Transitional care environment (Rehabilitation, assisted living, long term care, etc.) Home environment (House, mobile home, townhouse, apartment, etc.) Community setting (Office, school, retail, outdoors, etc.) Mobile environment (Car, plane, train, bus, ambulance, etc.) Medical devices may be used under variable conditions Crowded rooms The lighting level can be low The noise level can be high The room can be busy with other people and activities, providing distractions that can confuse the device operator.

15 User interface Logic of information display and control actions level of consistency with users abilities, expectations, and likely behaviors. Users experience with other similar user interface elements. Interactions Data entry (initial), data review, data revision, etc. Input - Knobs/dials, switches, buttons, keyboards, touch screens, etc. Output - Visual: displays (GUI), lights, control settings, etc. - Auditory: alerts/alarms, beeps, voice, motors, fans, etc. Identify safety critical tasks The design should address the following key areas - data, layout, feedback, and interaction

16 Example of UI considerations Mobile medical apps may pose additional or different risks due to the unique characteristics of the platform. For example, the interpretation of radiological images on a mobile device could be adversely affected by the smaller screen size, lower contrast ratio, and uncontrolled ambient light of the mobile platform

17 Risk mitigation strategies Designing out/controlling use-related hazards 1. Modify the device design to remove a hazard or reduce its consequences: Intuitive user interface, ensure that critical information is effectively communicated to the user. 2. Make the user interface, including its operating logic, error tolerant: Safety mechanisms such as physical safety guards, shielded controls, or software or hardware interlocks will make the design more tolerant of errors that users might make. 3. Alert users to the hazard: The device should detect when user error is not mitigated/eliminated and provide an adequate warning signal to users. 4. Develop written procedures and training for safe operation: If it is impossible to eliminate or mitigate hazards through any of the previous strategies. Millers Law don t rely on the user to remember (max 7 tasks). Trial and error not all users reads the manual.

18 Usability testing Conduct studies iteratively to optimize the SW design and ensure that the human factors/usability validation testing results will be successful. Design verification: Verifies a user interface of a device by inspection, by making sure that it fulfill pre-established requirements and that it performs the intended functions. Design validation: Demonstrates and provides evidence that a medical device, as designed, can be used safely and effectively.

19 Usability testing Product mock ups or early prototypes operating in simulated use modes for verification. Use finalized device design and labeling for validation. Test participants should be representative of the intended user population(s). Test environment that closely simulates (or is) the actual usage environment and typical usage conditions. Consider screen orientation. Consider how the user will hold the device. Is it likely to be used with one hand or two? For any text entry, consider whether the users will one finger type or will be likely to double-finger or double thumb-type. Will this affect performance? Are there any other environmental requirements? For example, if the device is to be used in surgery, test the use with a case/cover that meets surgical standards. Allow realistic device user interactions

20 Documentation Usability Engineering File Documents and references work produced from the usability engineering process Structure according to requirements of IEC FDA HFE/UE report Structure according to FDA draft guidance Two separate reports for FDA. US requires both! UE file can be used to provide input for FDA report

21 SUMMING UP

22 Key points Prevent medical error! - design safe Medical Applications One in three device incidents relate to use error (FDA). Do usability testing to optimize the App design start early Avoid interface problems late in the development process (shorter time to market) Satisfied users - Product with the the Core Clearer regulatory compliance Every product gets tested for usability eventually. Users perform usability testing on your product every time they use it, and they render their verdict through their continued use or lack thereof.

The FDA Perspective on Human Factors in Medical Device Software Development

The FDA Perspective on Human Factors in Medical Device Software Development The FDA Perspective on in Medical Device Development Molly Follette Story, PhD FDA /CDRH / ODE 2012 IQPC Design for Medical Devices Europe Munich, Germany Februar y1, 2012 Overview Guidance for FDA premarket

More information

FDA Perspectives on Human Factors in Device Development

FDA Perspectives on Human Factors in Device Development FDA Perspectives on in Device Development Molly Follette Story, PhD FDA /CDRH / ODE Understanding Regulatory Requirements for Usability Testing RAPS Webinar June 7, 2012 Overview What are human factors

More information

WHITEPAPER: SOFTWARE APPS AS MEDICAL DEVICES THE REGULATORY LANDSCAPE

WHITEPAPER: SOFTWARE APPS AS MEDICAL DEVICES THE REGULATORY LANDSCAPE WHITEPAPER: SOFTWARE APPS AS MEDICAL DEVICES THE REGULATORY LANDSCAPE White paper produced by Maetrics For more information, please contact global sales +1 610 458 9312 +1 877 623 8742 globalsales@maetrics.com

More information

Overview of Medical Device Design Controls in the US. By Nandini Murthy, MS, RAC

Overview of Medical Device Design Controls in the US. By Nandini Murthy, MS, RAC Overview of Medical Device Controls in the US By Nandini Murthy, MS, RAC 18 controls are a regulatory requirement for medical devices. In the US, compliance with the design controls section of 21 Code

More information

Medical Device Software - Software Life Cycle Processes

Medical Device Software - Software Life Cycle Processes 1 Medical Device Software - Software Life Cycle Processes IEC 62304 2 Credits John F. Murray Software Compliance Expert U.S. Food and Drug Administration Marcie R. Williams Medical Device Fellow Ph.D.

More information

The U.S. FDA s Regulation and Oversight of Mobile Medical Applications

The U.S. FDA s Regulation and Oversight of Mobile Medical Applications The U.S. FDA s Regulation and Oversight of Mobile Medical Applications The U.S. FDA s Regulation and Oversight of Mobile Medical Applications As smart phones and portable tablet computers become the preferred

More information

Regulatory expectations on user engagement for medical devices

Regulatory expectations on user engagement for medical devices Regulatory expectations on user engagement for medical devices World Usability Day 2014 - Enschede November 13 Sonja Paus-Buzink PhD Managing Human Factors Specialist Human Factors Engineering UL and the

More information

Risk Assessment for Medical Devices. Linda Braddon, Ph.D. Bring your medical device to market faster 1

Risk Assessment for Medical Devices. Linda Braddon, Ph.D. Bring your medical device to market faster 1 Risk Assessment for Medical Devices Linda Braddon, Ph.D. Bring your medical device to market faster 1 My Perspective Work with start up medical device companies Goal: Making great ideas into profitable

More information

Introduction into IEC 62304 Software life cycle for medical devices

Introduction into IEC 62304 Software life cycle for medical devices Introduction into IEC 62304 Software life cycle for medical devices Christoph Gerber 4. September 2008 SPIQ 9/5/2008 1 Agenda Current Picture Regulatory requirements for medical device software IEC 62304

More information

How to Develop an Effective Design Control Program: A Life-Cycle Multi-Phase Approach

How to Develop an Effective Design Control Program: A Life-Cycle Multi-Phase Approach GMP How to Develop an Effective Design Control Program: A Life-Cycle Multi-Phase Approach Jackelyn Rodriguez This article provides a life-cycle methodology in a multi-phase approach that includes an effective

More information

Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management

Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management Guidance for Industry and FDA Premarket and Design Control Reviewers Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management Document issued on July 18, 2000 This document

More information

Medical Device Software Do You Understand How Software is Regulated?

Medical Device Software Do You Understand How Software is Regulated? Medical Device Software Do You Understand How Software is Regulated? By Gregory Martin Agenda Relevant directives, standards, and guidance documents recommended to develop, maintain, and validate medical

More information

Looking ahead to new human factors standards and guidances for medical devices. Ed Israelski - Convener IEC/ISO JWG Joint Working Group on Usability

Looking ahead to new human factors standards and guidances for medical devices. Ed Israelski - Convener IEC/ISO JWG Joint Working Group on Usability Looking ahead to new human factors standards and guidances for medical devices Human Factors and Ergonomics Society Healthcare Conference March 11, 2013 Ed Israelski - Convener IEC/ISO JWG Joint Working

More information

Regulatory Considerations for Medical Device Software. Medical Device Software

Regulatory Considerations for Medical Device Software. Medical Device Software Medtec Ireland 2015 Wireless Medical Devices Regulatory Considerations for Medical Device Software Kenneth L. Block, RAC October 7, 2015 Galway, Ireland Offices: Dallas, Texas (12 employees) Tokyo, Japan

More information

Medical Software Development. International standards requirements and practice

Medical Software Development. International standards requirements and practice Medical Software Development International standards requirements and practice Food and Drug Administration What? A public health agency Why? Protect American consumers How? By enforcing the Federal Food,

More information

Medical Device Software

Medical Device Software Medical Device Software Bakul Patel Senior Policy Advisor 1 Overview Medical devices and software Oversight principles and Current approach Trends, Challenges and opportunities Addressing challenges 2

More information

CDRH Regulated Software Looking back, looking forward

CDRH Regulated Software Looking back, looking forward CDRH Regulated Software Looking back, looking forward Medical Device Software Compliance Expert US Food & Drug Administration at the Regulatory Affairs Professional Society Indianapolis, Indiana Goal of

More information

The Regulation of Medical Device Apps

The Regulation of Medical Device Apps The Regulation of Medical Device Apps Prepared for West of England Academic Health Science Network and University of Bristol June 2014 June 2014 1 Table of Contents 1 Purpose...3 2 Scope...3 3 The Regulation

More information

codebeamer INTLAND SOFTWARE codebeamer Medical ALM Solution is built for IEC62304 compliance and provides a wealth of medical development knowledge

codebeamer INTLAND SOFTWARE codebeamer Medical ALM Solution is built for IEC62304 compliance and provides a wealth of medical development knowledge codebeamer Medical ALM Solution is built for INTLAND Traceability matrix Medical wiki Risk management IEC 62304 compliance codebeamer INTLAND codebeamer Medical ALM Solution is built for Medical Device

More information

JOURNAL OF MEDICAL INFORMATICS & TECHNOLOGIES Vol. 21/2012, ISSN 1642-6037

JOURNAL OF MEDICAL INFORMATICS & TECHNOLOGIES Vol. 21/2012, ISSN 1642-6037 JOURNAL OF MEDICAL INFORMATICS & TECHNOLOGIES Vol. 21/2012, ISSN 1642-6037 FDA, medical software, recall, safety of medical devices. Leszek DREWNIOK 1, Ewelina PIEKAR 1, Mirosław STASIAK 1, Remigiusz MANIURA

More information

Omni. A graphical point of sale designed for the future

Omni. A graphical point of sale designed for the future A graphical point of sale designed for the future Attractive, unique, and modern design Ergonomic, easy to use, and intuitive, on a touch screen or a standard keyboard Fully integrated payment solution

More information

Screen Design : Navigation, Windows, Controls, Text,

Screen Design : Navigation, Windows, Controls, Text, Overview Introduction Fundamentals of GUIs - methods - Some examples Screen : Navigation, Windows, Controls, Text, Evaluating GUI Performance 1 Fundamentals of GUI What kind of application? - Simple or

More information

Outline. Lecture 13: Web Usability. Top Ten Web Design Mistakes. Web Usability Principles Usability Evaluations

Outline. Lecture 13: Web Usability. Top Ten Web Design Mistakes. Web Usability Principles Usability Evaluations Lecture 13: Web Usability Outline Web Usability Principles Usability Evaluations Wendy Liu CSC309F Fall 2007 1 2 What Makes Web Application Development Hard? Target audience can be difficult to define

More information

CHAPTER 7 Expected Outcomes

CHAPTER 7 Expected Outcomes CHAPTER 7 SYSTEM DESIGN Expected Outcomes Able to know database design Able to understand designing form and report Able to know designing interfaces System Design A process of transforming from logical

More information

Mobile Medical Application Development: FDA Regulation

Mobile Medical Application Development: FDA Regulation Mobile Medical Application Development: FDA Regulation Mobile Medical Applications: Current Environment Currently over 100,000 mobile health related applications are available for download; there is an

More information

General Principles of Software Validation; Final Guidance for Industry and FDA Staff

General Principles of Software Validation; Final Guidance for Industry and FDA Staff General Principles of Software Validation; Final Guidance for Industry and FDA Staff Document issued on: January 11, 2002 This document supersedes the draft document, "General Principles of Software Validation,

More information

Medical Device Software Standards for Safety and Regulatory Compliance

Medical Device Software Standards for Safety and Regulatory Compliance Medical Device Software Standards for Safety and Regulatory Compliance Sherman Eagles +1 612-865-0107 seagles@softwarecpr.com www.softwarecpr.com Assuring safe software SAFE All hazards have been addressed

More information

Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance

Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Medical Product Development and FDA Regulations IEEE Orange County Computer Society March 27, 2006 Carl R. Wyrwa Medical Product Development and FDA Regulations Introduction Regulated FDA Overview Medical

More information

ORACLE CONSULTING GROUP

ORACLE CONSULTING GROUP ORACLE CONSULTING GROUP An Official United States Agent Firm for Foreign Establishments CONSULTING MEMORANDUM: DEALING WITH A MEDICAL DEVICE IN THE U.S. 5398 Golder Ranch Rd., Ste. 1 Tucson, Arizona 85739

More information

Common Industry Format Usability Tests

Common Industry Format Usability Tests Proceedings of UPA 98, Usability Professionals Association, Scottsdale, Arizona, 29 June 2 July, 1999 Common Industry Format Usability Tests Nigel Bevan Serco Usability Services 4 Sandy Lane, Teddington,

More information

Software-based medical devices from defibrillators

Software-based medical devices from defibrillators C O V E R F E A T U R E Coping with Defective Software in Medical Devices Steven R. Rakitin Software Quality Consulting Inc. Embedding defective software in medical devices increases safety risks. Given

More information

General Principles of Software Validation; Final Guidance for Industry and FDA Staff

General Principles of Software Validation; Final Guidance for Industry and FDA Staff General Principles of Software Validation; Final Guidance for Industry and FDA Staff Document issued on: January 11, 2002 This document supersedes the draft document, "General Principles of Software Validation,

More information

S3000 Quick-Start. The document describes the schedule of a configuration which is valid for the user software CDS 3.xx or higher.

S3000 Quick-Start. The document describes the schedule of a configuration which is valid for the user software CDS 3.xx or higher. The present document S3000 Quickstart does not replace a detailed study of the operating manual provided with the Safety Laser Scanner S3000. Please read the operating manual carefully before you handle

More information

Developing a Mobile Medical App? How to determine if it is a medical device and get it cleared by the US FDA

Developing a Mobile Medical App? How to determine if it is a medical device and get it cleared by the US FDA Developing a Mobile Medical App? How to determine if it is a medical device and get it cleared by the US FDA In this presentation: App stats: Explosive growth Examples already cleared by the US FDA Is

More information

Breakers and Switches. Machinery Directive EN60204 Health and safety requirements in machine design and manufacture

Breakers and Switches. Machinery Directive EN60204 Health and safety requirements in machine design and manufacture Breakers and Switches Machinery Directive EN60204 Health and safety requirements in machine design and manufacture Health and safety requirements in machine design and manufacturing Machine design and

More information

Guideline. Installation and commissioning Validation Operation and maintenance Modification Decommissioning

Guideline. Installation and commissioning Validation Operation and maintenance Modification Decommissioning Guideline Installation and commissioning Validation Operation and maintenance Modification Decommissioning Comments on this report are gratefully received by Johan Hedberg at SP Swedish National Testing

More information

Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development

Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development Draft Guidance for Industry and FDA Staff This guidance document is for comment purposes only.

More information

CTC Technology Readiness Levels

CTC Technology Readiness Levels CTC Technology Readiness Levels Readiness: Software Development (Adapted from CECOM s Software Technology Readiness Levels) Level 1: Basic principles observed and reported. Lowest level of software readiness.

More information

Leveraging PTC s Integrity Platform for IEC Compliance

Leveraging PTC s Integrity Platform for IEC Compliance Leveraging PTC s Integrity Platform for IEC 62304 Compliance SPK and Associates, LLC Our medical device customers report that up to 70% of new product innovation is being created in the software domain.

More information

MEDICAL DEVICE Cybersecurity.

MEDICAL DEVICE Cybersecurity. MEDICAL DEVICE Cybersecurity. 2 MEDICAL DEVICE CYBERSECURITY Introduction Wireless technology and the software in medical devices have greatly increased healthcare providers abilities to efficiently and

More information

White Paper: Designing Resourceful Graphical User Interfaces (GUIs) for Healthcare Applications

White Paper: Designing Resourceful Graphical User Interfaces (GUIs) for Healthcare Applications Accelerate Development Reduce Time to Product Automate Critical Tasks White Paper: Designing Resourceful Graphical User Interfaces (GUIs) for Healthcare Applications The ASHVINS GROUP, Inc. 6161 Blue Lagoon

More information

Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System

Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System NBOG s Best Practice Guide applicable for AIMDD, MDD, and IVDD 2014-3 Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System 1 Introduction The

More information

EVALUATION OF AUTOMATIC CLASS III DESIGNATION FOR STUDIO on the Cloud Data Management Software DECISION SUMMARY

EVALUATION OF AUTOMATIC CLASS III DESIGNATION FOR STUDIO on the Cloud Data Management Software DECISION SUMMARY A. DEN Number: DEN140016 EVALUATION OF AUTOMATIC CLASS III DESIGNATION FOR STUDIO on the Cloud Data Management Software B. Purpose for Submission: DECISION SUMMARY De novo request for adjunct data management

More information

Considerations for using the Web for Medical Device Applications

Considerations for using the Web for Medical Device Applications Considerations for using the Web for Medical Device Applications MEDS, San Diego August 23 rd, 2012 Daniel Sterling, President Who is Sterling? Your Partner in Medical Device Development What we do: o

More information

PoNET kbd48cnc. User s manual

PoNET kbd48cnc. User s manual PoNET kbd48cnc User s manual Version: 16/10/2012 SAFETY INFORMATION! This product is intended for integration by the user into a computer numerical control (CNC) machine. It is the user's responsibility

More information

The 4 Mindsets of Mobile Product Design. Scott Plewes

The 4 Mindsets of Mobile Product Design. Scott Plewes The 4 Mindsets of Mobile Product Design Scott Plewes With the recent popularity of smart phones and tablets, software product managers are under pressure to create mobile versions of their products for

More information

Safety of machinery Rules for the drafting and presentation of safety standards Edition 2,

Safety of machinery Rules for the drafting and presentation of safety standards Edition 2, CEN GUIDE 414 Safety of machinery Rules for the drafting and presentation of safety standards Edition 2, 2014-04-02 Contents Pages Foreword...3 1 Scope...5 2 Normative references...5 3 Terms and definitions...5

More information

Company Overview & Capabilities

Company Overview & Capabilities Company Overview & Capabilities Company Overview Mission Statement "The Mission of is to provide expert technical resources to our partners in order to develop concise and timely strategic solutions based

More information

Implementation of CVIS ITS Application in a Driving Simulator Environment Kenneth Sørensen, kenneth.sorensen@sintef.no SINTEF

Implementation of CVIS ITS Application in a Driving Simulator Environment Kenneth Sørensen, kenneth.sorensen@sintef.no SINTEF Denne artikel er publiceret i det elektroniske tidsskrift Artikler fra Trafikdage på Aalborg Universitet (Proceedings from the Annual Transport Conference at Aalborg University) ISSN 1603-9696 www.trafikdage.dk/artikelarkiv

More information

VPAT Summary. VPAT Details. Section 1194.22 Web-based Internet information and applications - Detail

VPAT Summary. VPAT Details. Section 1194.22 Web-based Internet information and applications - Detail Date: October 8, 2014 Name of Product: System x3755 M3 VPAT Summary Criteria Status Remarks and Explanations Section 1194.21 Software Applications and Operating Systems Section 1194.22 Web-based Internet

More information

Screen Design : Navigation, Windows, Controls, Text,

Screen Design : Navigation, Windows, Controls, Text, Overview Introduction Fundamentals of GUIs Screen Design : Navigation, Windows, Controls, Text, Evaluating GUI Performance - Methods - Comparison 1 Example: Automotive HMI (CAR IT 03/2013) 64, 68, 69 2

More information

A Risk Management Capability Model for use in Medical Device Companies

A Risk Management Capability Model for use in Medical Device Companies A Risk Management Capability Model for use in Medical Device Companies John Burton Vitalograph Ltd. Gort Rd. Business Park Ennis Ireland 353.65.686471 john.burton@vitalograph.ie Fergal Mc Caffery Lero

More information

Lucy Malby Business Development Manager eg technology Ltd

Lucy Malby Business Development Manager eg technology Ltd Lucy Malby Business Development Manager eg technology Ltd Design review, engineering prototype and design freeze Pre- clinical unit verification, clinical unit validation Engineering Prototype What is

More information

Supporting Features. Supports with Exceptions. Supports with Exceptions. Supports

Supporting Features. Supports with Exceptions. Supports with Exceptions. Supports Voluntary Product Accessibility Template (VPAT) Date: April 1, 2008 Name of Product: Kyocera FS-1100 (Desktop Laser Printer) Contact for more Information: William_cassidy@kyoceramita.com Section 1194.21

More information

Overview of International Medical Device Human Factors Standards. Ed Israelski PhD, Director of Human Factors Abbott Abbott Park, IL, USA

Overview of International Medical Device Human Factors Standards. Ed Israelski PhD, Director of Human Factors Abbott Abbott Park, IL, USA Overview of International Medical Device Human Factors Standards Ed Israelski PhD, Director of Human Factors Abbott Abbott Park, IL, USA Outline History of Medical Device Human Factors Standards Summary

More information

Tools for Testing Software Architectures. Learning Objectives. Context

Tools for Testing Software Architectures. Learning Objectives. Context Tools for Testing Software Architectures Wolfgang Emmerich Professor of Distributed Computing University College London http://sse.cs.ucl.ac.uk Learning Objectives To discuss tools to validate software

More information

Vigilance Reporting for Medical Devices in the EU. By Salma Michor, PhD, RAC

Vigilance Reporting for Medical Devices in the EU. By Salma Michor, PhD, RAC Vigilance Reporting for Medical Devices in the EU By Salma Michor, PhD, RAC 24 September 2009 Manufacturers putting medical devices on the market in the European Union (EU) must have a vigilance system

More information

For The Operating Room

For The Operating Room For The Operating Room OPERATING ROOM DAY SURGERY What is Merivaara INTEGRA? Service concept for creating functional workplaces together Integrates equipment and systems Improves workflow, increases efficiency

More information

Intland s Medical Template

Intland s Medical Template Intland s Medical Template Traceability Browser Risk Management & FMEA Medical Wiki Supports compliance with IEC 62304, FDA Title 21 CFR Part 11, ISO 14971, IEC 60601 and more INTLAND codebeamer ALM is

More information

What Medical Market Researchers Should Know about Usability Testing

What Medical Market Researchers Should Know about Usability Testing What Medical Market Researchers Should Know about Usability Testing Kay Corry Aubrey Usability Resources Inc Background Agenda What you will learn This presentation will be an appetizer on usability testing

More information

International Medical Device Regulators Forum (IMDRF) US FDA Center for Devices and Radiological Health - Update

International Medical Device Regulators Forum (IMDRF) US FDA Center for Devices and Radiological Health - Update International Medical Device Regulators Forum (IMDRF) US FDA Center for Devices and Radiological Health - Update Kimberly A. Trautman Associate Director, International Affairs Office of the Center Director

More information

Technology in Music Therapy and Special Education. What is Special Education?

Technology in Music Therapy and Special Education. What is Special Education? Technology in Music Therapy and Special Education What is Special Education? Disabilities are categorized into the following areas: o Autism, visual impairment, hearing impairment, deaf- blindness, multiple

More information

GUIDANCE NOTE FOR MANUFACTURERS OF CUSTOM-MADE MEDICAL DEVICES

GUIDANCE NOTE FOR MANUFACTURERS OF CUSTOM-MADE MEDICAL DEVICES GUIDANCE NOTE FOR MANUFACTURERS OF CUSTOM-MADE MEDICAL DEVICES Foreword This guidance document is informative and advisory and has no legal authority. Individual national enforcement authorities are bound

More information

How to Develop Accessible Linux Applications

How to Develop Accessible Linux Applications Sharon Snider Copyright 2002 by IBM Corporation v1.1, 2002 05 03 Revision History Revision v1.1 2002 05 03 Revised by: sds Converted to DocBook XML and updated broken links. Revision v1.0 2002 01 28 Revised

More information

Service Delivery Module

Service Delivery Module Service Delivery Module Software Development Methodology -India follows international industry standards and has adopted the standard methodology in our Software Development Life Cycle (SDLC). It is a

More information

Medical Devices. Notified Bodies and the CE certification Process for Medical Devices. European Surgical Robotics Demonstration Day

Medical Devices. Notified Bodies and the CE certification Process for Medical Devices. European Surgical Robotics Demonstration Day Medical Devices Notified Bodies and the CE certification Process for Medical Devices European Surgical Robotics Demonstration Day 27 th March 2014, Leuven, Belgium 1 Bart Mersseman Product Manager Medical

More information

Factory Acceptance Testing Guideline

Factory Acceptance Testing Guideline Factory Acceptance Testing Comments on this report are gratefully received by Johan Hedberg at SP Swedish National Testing and Research Institute mailto:johan.hedberg@sp.se -1- Summary According to the

More information

Cybage Electronic Medical Record (EMR) Usability

Cybage Electronic Medical Record (EMR) Usability White Paper Cybage Electronic Medical Record (EMR) Usability Table of Contents 01 1. Introduction 02 1.1 Usability Goals In EMR 03 1.2 Usability Principles In Action 03 1.2.1 Information Architecture 04

More information

Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices

Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices Draft Guidance for Industry and Food and Drug Administration Staff DRAFT GUIDANCE This guidance document

More information

Control and Indicating Equipment

Control and Indicating Equipment VdS Guidelines for Fire Detection and Fire Alarm Systems VdS 2540en Control and Indicating Equipment Requirements and Test Methods VdS 2540en : 2010-12 (02) Publishing house: VdS Schadenverhütung GmbH

More information

Safety Requirements Specification Guideline

Safety Requirements Specification Guideline Safety Requirements Specification Comments on this report are gratefully received by Johan Hedberg at SP Swedish National Testing and Research Institute mailto:johan.hedberg@sp.se -1- Summary Safety Requirement

More information

Webinar: Implications of FDA Regulation of Medical Devices: When is an ipad More Than an ipad?

Webinar: Implications of FDA Regulation of Medical Devices: When is an ipad More Than an ipad? Webinar: Implications of FDA Regulation of Medical Devices: When is an ipad More Than an ipad? Additional resources on this topic may be found at: www.aamc.org/fdamobiledevice Sharon Klein, Esq. Pepper

More information

CONTROL SYSTEM HiCOS. 12.1/1 HiCOS

CONTROL SYSTEM HiCOS. 12.1/1 HiCOS CONTROL SYSTEM HiCOS 12.1/1 HiCOS n Control for HV test systems and measuring devices n Easy and intuitive handling n Flexible and expandable design with modules n Acceleration of the workflow OvERvIEW

More information

How to Use the Design Process to Manage Risk: Elements of Design Controls and Why It Matters

How to Use the Design Process to Manage Risk: Elements of Design Controls and Why It Matters environmental failure analysis & prevention health technology development How to Use the Design Process to Manage Risk: Elements of Design Controls and Why It Matters Kevin L. Ong, Ph.D., P.E. Managing

More information

Effective Software Verification for Medical Devices

Effective Software Verification for Medical Devices STERLINGTECH AND KLOCWORK WHITE PAPER NOVEMBER 2009 Effective Software Verification for Medical Devices Achieving compliance and meeting productivity goals with static analysis In addition to producing

More information

Title: Basic Principles of Risk Management for Medical Device Design

Title: Basic Principles of Risk Management for Medical Device Design Title: Basic Principles of Risk Management for Medical Device Design WHITE PAPER Author: Ganeshkumar Palanichamy Abstract Medical devices developed for human application are used for diagnostic or treatment

More information

Michigan State University. Team Meijer. Tablet-Based Point-of-Sale System. Project Plan. Fall 2011

Michigan State University. Team Meijer. Tablet-Based Point-of-Sale System. Project Plan. Fall 2011 Michigan State University Team Meijer Tablet-Based Point-of-Sale System Project Plan Fall 2011 Meijer Contacts: Scott Pallas Murali Rajagopalan Team Members: Riti Adhi Peter Rifel Andrew Rockwell Mark

More information

Version: 1.0 Latest Edition: 2006-08-24. Guideline

Version: 1.0 Latest Edition: 2006-08-24. Guideline Management of Comments on this report are gratefully received by Johan Hedberg at SP Swedish National Testing and Research Institute mailto:johan.hedberg@sp.se Quoting of this report is allowed but please

More information

Implementation of ANSI/AAMI/IEC 62304 Medical Device Software Lifecycle Processes.

Implementation of ANSI/AAMI/IEC 62304 Medical Device Software Lifecycle Processes. Implementation of ANSI/AAMI/IEC 62304 Medical Device Software Lifecycle Processes.. www.pharmout.net Page 1 of 15 Version-02 1. Scope 1.1. Purpose This paper reviews the implementation of the ANSI/AAMI/IEC

More information

ISMS Implementation Guide

ISMS Implementation Guide atsec information security corporation 9130 Jollyville Road, Suite 260 Austin, TX 78759 Tel: 512-615-7300 Fax: 512-615-7301 www.atsec.com ISMS Implementation Guide atsec information security ISMS Implementation

More information

Naturally Safe Software User Interfaces

Naturally Safe Software User Interfaces Applying Human Factors Engineering Naturally Safe Software User Interfaces Michael Wiklund and Jonathan Kendler Stimulated by regulations and standards 1,2 as well as commercial imperatives, medical device

More information

A Software Engineering Model for Mobile App Development

A Software Engineering Model for Mobile App Development APPENDIX C A Software Engineering Model for Mobile App Development As we mentioned early in the book (see Chapter 1), to successfully develop a mobile software solution you should follow an engineering

More information

MOBILE MEDICAL APPLICATIONS

MOBILE MEDICAL APPLICATIONS October 7, 2013 EVOKE HEALTH POINT OF VIEW MOBILE MEDICAL APPLICATIONS FDA GUIDANCE FOR INDUSTRY FOR MORE INFORMATION: Mark McConaghy, VP, Strategy Evoke Health 267.765.4998 mark.mcconaghy@evokehealth.com

More information

Changing Regulatory Requirements for Electronic Medical Devices Dirk Smith Co-Founder Minnetronix Inc.

Changing Regulatory Requirements for Electronic Medical Devices Dirk Smith Co-Founder Minnetronix Inc. Changing Regulatory Requirements for Electronic Medical Devices Dirk Smith Co-Founder Minnetronix Inc. 250 employees, 20 years in business 130+ Class II/Class III device programs in our history 100+ engineers

More information

Alaskans experiencing mental illness, brain injury, FASD, other cognitive impairments WHO?

Alaskans experiencing mental illness, brain injury, FASD, other cognitive impairments WHO? Heidi Frost Statewide Independent Living Council Kate Burkhart Alaska Mental Health Board October, 2012 Alaskans experiencing mental illness, brain injury, FASD, other cognitive impairments WHO? A Different

More information

Clinical evaluation Latest development in expectations EU and USA

Clinical evaluation Latest development in expectations EU and USA Clinical evaluation Latest development in expectations EU and USA Medical Devices: staying ahead of regulatory developments Gert Bos BSI Israel 22 April - Herzliya Copyright 2012 BSI. All rights reserved.

More information

The Shifting Sands of Medical Software Regulation

The Shifting Sands of Medical Software Regulation The Shifting Sands of Medical Software Regulation Suzanne O Shea Ralph Hall September 10, 2014 What Software is Regulated by FDA? FDA regulates medical devices. FDA regulates software that meets the definition

More information

Gallagher Vapour Recovery Monitoring

Gallagher Vapour Recovery Monitoring Gallagher Vapour Recovery Monitoring VR Site Monitoring The status display enables site operators to comply with VR legislation. The laws and guidelines for the New South Wales Vapour Recovery regulations

More information

Elements of robot assisted test systems

Elements of robot assisted test systems 1 (9) Matti Vuori, 2013-12-16 RATA project report Elements of robot assisted test systems Table of contents: 1. General... 2 2. Overall view to the system the elements... 2 3. There are variations for

More information

2015. All rights reserved.

2015. All rights reserved. DOCUMENT: Future AAMI/IEC 62304:2006/AMD1, 18-August-2015 Final Draft International Standard for Vote, Amendment 1 to IEC 62304: Medical device software Software life cycle processes. Public Review Draft

More information

FDA Releases Final Cybersecurity Guidance for Medical Devices

FDA Releases Final Cybersecurity Guidance for Medical Devices FDA Releases Final Cybersecurity Guidance for Medical Devices By Jean Marie R. Pechette and Ken Briggs Overview and General Principles On October 2, 2014, the Food and Drug Administration ( FDA ) finalized

More information

Backbase Accessibility

Backbase Accessibility Whitepaper Learn about: Section 508 Accessibility requirements Backbase compliance Introduction This paper discusses the growing importance of Rich Internet Applications (RIA s) and their support for Accessibility.

More information

AN APPLICATION STUDY FOR THE CLASS IE DIGITAL CONTROL AND

AN APPLICATION STUDY FOR THE CLASS IE DIGITAL CONTROL AND - 39 - AN APPLICATION STUDY FOR THE CLASS IE DIGITAL CONTROL AND MONITORING SYSTEM m,,,.,.., HIROYUKIFUKUMITSU Nuclear Power Plant Department, EISC MITSUBISHI ELECTRIC CORPORATION Kobe, Japan XA9846493

More information

Full Link: http://www.modernhealthcare.com/article/20140816/magazi NE/308169986. Health IT poses safety problems if users not trained properly

Full Link: http://www.modernhealthcare.com/article/20140816/magazi NE/308169986. Health IT poses safety problems if users not trained properly Full Link: http://www.modernhealthcare.com/article/20140816/magazi NE/308169986 Health IT poses safety problems if users not trained properly By Sabriya Rice August 16, 2014 To improve patient safety,

More information

Simplified Machine Vision Verification of 1D and 2D Barcodes

Simplified Machine Vision Verification of 1D and 2D Barcodes Simplified Machine Vision Verification of 1D and 2D Barcodes 1 Presented by Steven J. King Machine Vision Product Manager at Microscan 2 About Microscan Founded in 1982, technology innovator and leader

More information

Design Controls: Are They Worth the Effort?

Design Controls: Are They Worth the Effort? Design Controls: Are They Worth the Effort? Compliance-Alliance conducted a survey to measure the effects of FDA s design control regulation on the industry. Most respondents believe the controls have

More information

3 Introduction to HCI - Human Factor Theories - Mental Models and Problem Solving. Mental models are useful example: the bath tub faucets

3 Introduction to HCI - Human Factor Theories - Mental Models and Problem Solving. Mental models are useful example: the bath tub faucets Design thinking Human Factor Theories Part I - Mental Model & Problem Solving School of Computer and Communication Sciences EPFL Dr. Pearl Pu What is common in all of these? 2 Mental Models The first question:

More information

Developing accessible portals and portlets with IBM WebSphere Portal

Developing accessible portals and portlets with IBM WebSphere Portal Developing accessible portals and portlets with IBM WebSphere Portal Level: Introductory IBM Human Ability and Accessibility Center Austin, Texas February, 2006 Copyright International Business Machines

More information

A graphical point of sale designed for the future

A graphical point of sale designed for the future A graphical point of sale designed for the future Attractive, unique, and modern design Ergonomic, easy to use, and intuitive, on a touch screen or a standard keyboard Fully integrated payment solution

More information

Bringing Legacy Medical Devices into Usability Compliance. Shannon Clark 4/29/2015

Bringing Legacy Medical Devices into Usability Compliance. Shannon Clark 4/29/2015 Bringing Legacy Medical Devices into Usability Compliance Shannon Clark 4/29/2015 Agenda What is a legacy device? Background on Usability Engineering Standards What is the roadmap for bringing legacy devices

More information