Medical Devices Professional Training for the Medical Engineering Sector Modular Qualifications and Seminars TÜV SÜD Akademie GmbH
Experience, Expertise and Innovation for the Medical Device Industry Dear Sir or Madam, The Hamburg Institute of International Economics forecasts that by 2020 the demand for medical devices will have increased by an annual 4% in the USA and Western Europe, by 8% in Eastern Europe and by more than 10% in China and India. However, this fast-growing market lacks skilled specialists. Manufacturers of medical devices wishing to place their products on the market must overcome particularly high obstacles. Approval procedures are complex and differ significantly across non-eu markets. In particular, there is a scarcity of specialists with the ability to help new medical devices to navigate the jungle of very diverse international approval procedures. TÜV SÜD Academy provides support, offering modular qualifications and seminars: Manager Regulatory Affairs International TÜV Specialist Medical Software TÜV Safety Expert (Non-) Active Medical Devices TÜV All seminars are offered individually or as intensive seminars on request, also as customized training and in-house training. Our programme also covers further topics related to medical devices. Workshop and consulting packages are also available on demand. Kind regards, Birgit Klusmeier TÜV SÜD Akademie Anita Lenzser TÜV SÜD Akademie 2
Registration of medical devices on international markets Modular Qualification: Manager Regulatory Affairs International TÜV Certificate: Manager Regulatory Affairs International TÜV after successful completion of the foundation and advanced modules Registration of Medical Devices in the Middle and Far East Registration of Medical Devices Outside the EU Registration of Medical Devices in the USA Foundation and Advanced Courses US FDA QM Requirements in Accordance with 21 CFR 820 QSReg/GMP in Comparison to Europe Certificate of Manager Regulatory Affairs TÜV Certificate of Specialist Management Systems TÜV Management Systems for Medical Device Manufactures Objektive Advanced Modules Objektive Objektive Advanced Modules Certificate of Specialist Technical Documentation TÜV Technical Documentation Risk Analysis Clinical Evaluation TÜV SÜD Academy s modular qualification, Regulatory Affairs, offers training modules that are suitable to all needs and abilities from the foundation course for beginners to qualification as Manager Regulatory Affairs International TÜV. We inform you about the certification requirements imposed by the Notified Bodies and show you how to launch your medical devices successfully on international markets. After completing the relevant training courses in one of the modules you can take an examination to document your qualifications in a certificate: Specialist Management Systems TÜV Furnishes evidence of your expertise in medical device law and management systems and enables you to accompany the approval of medical devices in the European Economic Area (EEA). Specialist Technical Documentation TÜV Provides you with the qualifications required for preparing technical documentation and enables you to assist in the approval of medical devices in the European Economic Area (EEA). In addition, the examination shows that you are familiar with the requirements related to clinical evaluation and risk management. Manager Regulatory Affairs TÜV After passing the Specialist Management Systems TÜV and Specialist Technical Documentation TÜV examinations, you acquire the qualification of Manager Regulatory Affairs TÜV and can assume responsibility for the approval of your medical devices in the EU. Manager Regulatory Affairs International TÜV In addition to Manager Regulatory Affairs TÜV qualification, you can demonstrate expertise in quality assurance and approval on key international markets. Foundation Module 4 5
Manager Regulatory Affairs International TÜV Training Courses: Regulatory Affairs The seminar familiarizes you with the fundamentals of the EU Medical Device Directives plus amendment directive 2007/47/EC, focusing in particular on special requirements of the European market. In addition, the seminar summarizes the various conformity assessment procedures and the relevant procedural standards. Management Systems for Medical Device Manufacturers Management systems for medical device manufacturers are governed by the EN ISO 13485:2012 standard. The seminar helps you to understand and implement in your organization the requirements applicable to management systems for manufacturers of medical devices. Clinical Evaluation of Medical Devices The seminar informs you about the criteria set forth in the relevant directives and laws for determining and providing clinical data within the scope of the conformity assessment of medical devices. Risk Management and Risk Analysis for Medical Devices in Accordance with the EN ISO 14971:2012 Standard The EU Medical Device Directive requires risk analysis to be carried out for each individual medical device. This course familiarizes you with applicable criteria of the relevant standards. Registration of Medical Devices in the USA Foundation and Advanced course on How to Prepare a 510(k) Application All medical devices to be placed on the US market must comply with the strict requirements of the FDA, the US authority responsible for the registration of medical devices. The foundation course familiarizes you with the FDA requirements. In the advanced course, you will learn how to prepare a 510(k) application. Registration of Medical Devices Outside the EU This course explains the requirements that must be fulfilled in countries like Brazil and Mexico to have your medical devices registered by the competent authorities there. Registration of Medical Devices in the Middle and Far East The introduction of new regulations governing export to the Middle and Far East brings new challenges for the manufacturers of medical devices. This seminar informs you about the various approval and framework conditions in the key target markets. Note: The seminars can be booked individually or as a Manager Regulatory Affairs International TÜV intensive seminar. The content of the training correspond to the current revison/harmonization. Technical Documentation for Medical Devices This seminar provides guidance on the systematic establishment and revision of technical documentation for medical devices in accordance with the applicable EU Directives. US FDA QM Requirements in Accordance with 21 CFR 820 QSReg/GMP in Comparison to Europe The US regulatory requirements for medical devices and their implementation differ fundamentally from those in the EU market. This seminar informs you about the QM requirements in the USA and their application. 6 7
Development of active or non-active medical devices Modular Qualification: Safety Expert (Non-) Active Medical Devices TÜV Certificate Safety Expert Active Medical Devices TÜV Functional Safety Foundation and Advanced Courses Objective Certificate Safety Expert Non-Active Medical Devices TÜV Sterilization of Medical Devices Foundation and Advanced Courses Safety Expert Active Medical Devices TÜV By passing this examination you can demonstrate your expertise in the safety-related requirements for active medical devices. You are particularly familiar with functional safety and the requirements for electrical safety set forth in the IEC 60601-1, 3rd edition standard. Safety Expert Non-Active Medical Devices TÜV By passing this examination you can prove your expertise in the safetyrelated requirements for non-active medical devices. The examination focuses particularly on the requirements related to biological evaluation in accordance with the EN ISO 10993 standard and sterilization processes. Electrical Safety Foundation and Advanced Courses Advanced Modules Biological Safety Medical Devices Design and Development Management Medical Device Law foundation course Foundation Modules TÜV SÜD Academy s Safety Expert modular qualification provides comprehensive training from the foundation course for beginners to Safety Expert Active Medical Devices TÜV and Safety Expert Non-Active Medical Devices TÜV qualification. The seminar qualifies professionals in design departments to develop active or non-active medical devices in compliance with the applicable standards and laws and prepare the associated technical documentation. After completing the relevant training courses in one of the modules you can take an examination to document your qualifications in a certificate: 8 9
Safety Expert (Non-) Active Medical Devices TÜV Training Courses: Safety Expert The seminar familiarizes you with the fundamentals of the EU Medical Device Directives plus amendment directive 2007/47/EC, focusing in particular on special requirements of the European market. In addition, the seminar summarizes the various conformity assessment procedures and the relevant procedural standards. Medical Devices Design and Development Management This seminar provides an introduction to the regulatory requirements defined for the design and development process of medical devices. The seminar outlines the concept of the directive and the relevant reference in the Medical Device Directive (MDD). We familiarize you with the quality management requirements in accordance with ISO 13485, focusing on Sections 7.1 7.4 of product realization. Biological Safety of Medical Devices Biological safety is one of the key aspects for implants and medical devices in direct or indirect contact with the body. The devices must be biologically safe, i.e. rejection by the body, sepsis, inflammatory responses or other complications caused by the devices should be avoided. This seminar teaches you the required biocompatibility testing to ensure the biological safety of medical devices in accordance with the EN ISO 10993 series of standards. Sterilization of Medical Devices Foundation and Advanced Courses The seminar explains the essential requirements for the sterilization of medical devices and hygiene monitoring as a basis of sterilization validation. Building on the knowledge acquired in the foundation course, the advanced course familiarizes you with the special aspects of the various sterilization processes. Safety of Medical Electrical Equipment IEC 60601-1, 3rd Edition Foundation and Advanced Courses The international standard IEC 60601-1, 3rd edition, defines the requirements for the basic safety of medical electrical equipment. The requirements established in the standard must be taken into consideration in the design of medical devices. Our foundation course explains the structure and safety philosophy of the standard and familiarizes you with the fundamentals of the required tests. The advanced course addresses and explains the electrical safety requirements. Functional Safety of Medical Devices Foundation and Advanced Courses on the Safety of Computer-Controlled Devices The objective of functional safety is to design medical devices that identify possible technological defects before they turn into problems and pose hazards. Building on the foundation course that presents the applicable standards and the basic principles of functional safety, the advanced course provides in-depth knowledge of the various methods of performing automatic self-tests for computer components. Note: You can book the seminars individually or as a Safety Expert (Non-) Active Medical Devices TÜV intensive seminar. The content of the training correspond to the current revison/ harmonization. 10 11
Software development for medical devices Modular Qualification: Specialist Medical Software TÜV Certificate: Specialist Medical Software TÜV after successful completion of the foundation and advanced modules Objective Implementation of the Software Standard IEC 62304 for the Manufacturers of Medical Devices In addition, applying the EN 62366:2008 and IEC 60601-1-6:2010 standards, you are able to develop software products offering optimum usability. Last but not least, you are familiar with the process of integrating the software lifecycle into the quality management and the risk management systems. After completing the training courses in one of the modules you can take an examination to document your qualifications in certificates for the individual topics. Usability of Medical Devices in Accordance with EN 62366:2008 and IEC 60601-1-6:2010 Risk Management and Risk Analysis for Medical Devices in Accordance with EN ISO 14971:2012 Standard Advanced Modules Foundation Module Software is an important element in many medical devices. To ensure the safety and effectiveness of medical devices, experts need to know the desired software functions and how to ensure that these functions safely achieve the desired effects. The requirements established in the applicable laws and standards must be considered right from the outset of software design and development. By passing the examination you prove that you are able to ensure the development and integration of medical software in accordance with the relevant standards. You thus contribute to the safety of software products. You are familiar with the contents of the Medical Device Directive (MDD), know medical device law and understand risk management in accordance with EN ISO 14971:2012. 12 13
Specialist Medical Software TÜV Training Courses: Medical Software The seminar familiarizes you with the fundamentals of the EU Medical Device Directives plus amendment directive 2007/47/EC, focusing in particular on special requirements of the European market. In addition, the seminar summarizes the various conformity assessment procedures and the relevant procedural standards. Risk Management and Risk Analysis for Medical Devices in Accordance with EN ISO 14971:2012 Standard The EU Medical Device Directive requires risk analysis to be carried out for each individual medical device. This course familiarizes you with applicable criteria of the relevant standards. Individualized qualification for you In-House Seminars: Customized Training Directly at Your Company s Premises What would you say to knowledge and advanced training that are delivered to your door? TÜV SÜD Academy s experienced education experts develop and realize individual training measures for you and your organization. We start by working with you to prepare a detailed analysis of your situation and training needs. Building on the results obtained in this analysis, we define your educational and training objectives and develop in-house seminars tailored to your needs. You benefit from a targeted qualification programme, including seminar preparation, evaluation of achievements and ensuring transfer of learning, implemented on-site in your company. Usability of Medical Devices in Accordance with EN 62366:2008 and IEC 60601-1-6:2010 Usability and ergonomics have become key quality and performance characteristics of medical devices. The two standards EN 62366 and IEC 60601-1-6, harmonized under the Medical Device Directive (93/42/EEC), define how to take usability aspects into account in the design and development process of medical devices. In this seminar, you learn to understand and meaningfully implement the requirements of the EN 62366 (IEC 62366 and IEC 60601-1-6) standard. Implementation of the Software Standard IEC 62304 for the Manufacturers of Medical Devices The seminar offers a practice-focused approach to the IEC 62304 standard. The implementation of this software standard poses a challenge for many manufacturers of medical devices as it requires a large number of processes, some of which are new. You obtain a basic overview of the key contents of the standard and the required processes that describe the software lifecycle. Based on practice assignments, we will exercise the application and implementation of the standard in terms of process design and documentation. Note: You can book the seminars individually or as a Specialist Medical Software intensive seminar. The content of the training correspond to the current revison/harmonization. Your benefits:! You define contents, framework and process in accordance with your needs. We provide staff training directly at your company s premises, saving you travel and accommodation costs. You ensure that participants that have different previous knowledge reach an uniform level of knowledge. You benefit from our longstanding experience in training and education at large multinationals and SMEs. From Europe, to the Americas and Asia Pacific at your request we will be happy to provide international training. 14 15
Knowledge that makes the difference www.tuev-sued.de/academy TÜV SÜD Akademie GmbH Westendstrasse 160 80339 Munich Germany Phone: +49 (0) 89 5791-3691 E-Mail: akd.medicaldevices@tuev-sued.de Let s stay in touch! AC29-MedDevEng-fly-105x210-w-15-04-20