Turning our experience into your expertise. Medical devices training

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1 Turning our experience into your expertise Medica devices training

2 A eading training academy. Annuay we train in excess of 4000 peope. More than 70% of the top 100 medica device companies were trained by us and our technica trainers have a combined industry and reguatory experience of over 546 years. Word-eading industry subject matter experts, over 200 BSI Medica Device product and reguation experts. Course instructors are active practitioners in their subjects, ensuring the atest deveopments are fuy understood. State of the art courses, representing up-to-date thinking on the current and possibe future interpretations of the directives, standards and guidance. Acceerated earning phiosophy you don t just sit and isten, you experience the subject. You participate in hands-on exercises, case studies, group work, mock rea ife situations and earning aids incuding photos, charts, games and quizzes. On-ine, pubic or in-house course its your choice. We schedue pubic courses for you to book onto or if you prefer to have a group of empoyees attend a course together, choose in-house. Courses can be customised to your requirements. Cost efficient A BSI training course can provide you with the knowedge to save significant time and money in bringing your product to market. Make exceence a habit BSI training wi prepare you to take the exceence habit back to your business. medicadevices.bsigroup.com/training 2 BSI Medica Devices Training

3 Norway Each country offers a variety of training venues in city ocations or at airports to faciitate deegates trave arrangements. Airport Training ocation Denmark Goteborg Copenhagen Mamo Ireand UK Manchester Nottingham Birmingham Amsterdam Miton Keynes Luton Swindon Bristo Heathrow Stansted London London City Gatwick Netherands Germany Antwerpen Begium Frankfurt France Darmstadt Luxembourg Paris Our venues We deiver five star earning at first cass venues. Venues are seected specificay to make sure you earn in the best possibe environment with great faciities, refreshments and quaity accommodation. This way you can focus on and maximize your earning experience. Aso, any of our pubic courses can be taiored to your specific needs and deivered at your premises making it even more convenient for you. 99% of course deegates say they woud recommend BSI. Here are some of their reasons for doing so: Experience and breadth of training Brand association Choice of course stye Ease of booking Quaity course materia Reputabe venues Remember if you want a training course to be run at your pace of work, pease tak to our training team on +44 (0) % of course attendees woud highy recommend BSI Training BSI Medica Devices Training 3

4 Medica device training courses. CE marking Introduction to CE marking Attend Introduction to CE marking course and start making informed decisions with regards to meeting the requirements of the EU Medica Devices Directives. On competion, you wi be abe to identify the steps required to reduce the risks and uncertainty in the EU reguatory process and thus bring products to the EU market more quicky. Medica Devices CE marking The medica devices CE marking course is designed to provide participants with the knowedge to assist their companies in getting products to market quicky. You wi gain knowedge of the requirements of the Medica Device Directive and the CE marking approach. Participants wi be abe to provide eadership for their organizations when pacing medica devices on the market in the European Union. Course duration: 3 days Introduction to CE marking for the In Vitro Diagnostics Directive This BSI course has been designed to introduce the In Vitro Diagnostics Directive (IVDD), the types of product covered by the Directive and the reguatory framework required for pacing IVD products on the European market. Participants wi gain knowedge about the directive and the deveopment of IVD products as we as their on-going maintenance to achieve continued reguatory compiance throughout the ifecyce of the product. Appication of the In Vitro Diagnostics Directive Appication of the In Vitro Diagnostics Directive course has been designed to enabe you to expore the IVD Directive, gain a greater understanding of the requirements and thus enabe your IVD devices to be paced on the European market efficienty. You wi be abe to appy the requirements of the directive to create technica documentation to support the product throughout its ifecyce. Course duration: 3 day This course was exceent. The tutor deivered the course at a good pace pitched at an appropriate eve Michae Dibbens, St Thomas Hospita ISO Introduction to ISO Medica Devices BSI s Introduction to: ISO course has been designed to provide an insight in to the use of ISO as the basis for a Quaity Management System impemented by medica device manufacturers. Time wi be spent during the course reviewing requirements of ISO and making comparisons to ISO 9001 and the FDA s Quaity System Reguation. In addition to this, participants wi aso gain an awareness of the reationship between ISO and ISO 14971, Appication of Risk Management to Medica Devices. Impementing ISO Medica Devices BSI s Impementing ISO course has been designed to provide you with the knowedge and process steps to enabe them to effectivey impement a Quaity Management System in ine with the requirements for ISO certification. The course introduces the concepts needed to understand, deveop, and impement a quaity management system. Course duration: 2 days Interna Auditor ISO Medica Devices BSI s Interna Auditor ISO course is intended for medica device quaity professionas aiming to buid on their current knowedge of ISO and evauate the effectiveness of the quaity management system in their organization. This intensive course teaches the principes and practices of effective quaity management systems process audits in accordance with the ISO and ISO An experienced instructor guides students through the interna audit process, from panning an audit to reporting on audit resuts and foowing up on corrective actions. Participants wi gain necessary auditing skis through a baance of forma cassroom tutorias, practica roe-paying, and group workshops. Course duration: 2 days Lead Auditor ISO Medica Devices BSI s Lead Auditor ISO course teaches the principes and practices of effective quaity management systems and process audits in accordance with ISO and ISO 19011, Guideines for Quaity and/or Environmenta Management Systems Auditing. Experienced instructors guide students through the entire audit process, from managing an audit programme to reporting on audit resuts. Participants wi gain necessary auditing skis through a baance of forma cassroom tutorias, practica roe-paying, group workshops, and open forum discussions. Course duration: 5 days 4 BSI Medica Devices Training Book onine at medica.devices.bsigroup.com/training or ca +44 (0)

5 Speciaist courses Medica Devices Risk Management ISO This course is designed to provide participants with an understanding of the impact that ISO has on the decision making process at medica device manufacturing firms. This course heps medica device professionas gain an understanding of how ISO can improve their business and risk management efforts. Participants wi aso understand how ISO appies to ISO The training incudes exercises, and participants wi have the chance to ask questions about how ISO and risk management appy to their organizations. Writing Technica Fies for Compiant Devices BSI s Writing Technica Fies for Compiant Devices course is designed to support manufactures by confirming current reguatory requirements of technica documentation. The aim of the course is to speed up the certification process and enabe manufacturers to se compiant devices within the European Union. On competion of the training you wi be abe to identify and ocate a reguatory requirements and guidance documentation necessary to write procedures enabing the creation and maintenance of compiant technica fies and design dossiers. Cinica Evauation for Medica Devices BSI s Cinica Evauation for Medica Devices course is designed to support manufacturers by confirming the information necessary to demonstrate cinica safety and performance of their product in accordance with the requirements of the European Medica Devices Directive. On competion of training, manufacturers wi be abe to determine if a cinica tria is required, prepare a cinica evauation report incuding iterature review and determine requirements for post-market cinica foow-up and post-market surveiance to support continuing compiance. Post-Market Surveiance and Vigiance Post-market surveiance incuding cinica foow-up, compaint and vigiance handing, impacts on a aspects of the Quaity Management System. Proactive and reactive sources of information are a reguatory requirement to be incorporated in your post-market surveiance procedures appicabe to a products. Obtaining the right postmarket information wi ensure continued compiance with the directives and identify consumer needs enabing continued product deveopment. BSI s Post-Market Surveiance and Vigiance course is designed to hep you identify the requirements of the European Medica Device Directives, standards and guidance documents to enabe effective impementation of a post market surveiance system. Process Vaidation for the Medica Device Industry BSI s Process Vaidation for the Medica Device Industry course has been designed to hep manufacturers gain awareness of quaity requirements regarding vaidation and the nature of specia processes. Learn the generay accepted principes of vaidation, and introduce how-to-do methods of instaation, operationa, and process quaification. Device-Drug Combinations: Practica Guidance on Borderine Issues and the Consutation Process This speciaized course has been designed to provide manufacturers with the knowedge and skis to interpret the requirements of the drug consutation process for devices containing anciary medicina substances. The course wi provide guidance on how to reduce risks and uncertainty in the EU reguatory process. The course focuses on determination of the appicabe European egisation for borderine products, and provides insight into further information and guidance reated to the distinction between medica devices and medicina products. and examines devices incorporating derivatives of human bood or pasma. CE marking Medica Devices with Software When it comes to creating, testing, and maintaining software, there are often grey areas. However, when your software appies to a medica device, the steps you take to define, cassify, deveop, and test your software become critica to both your business and patient heath. Achieving and maintaining a CE mark for your medica software is essentia to keeping your product marketabe. For those organizations that are unsure how the medica device directives appy to their software, how their software is cassified, and how to deveop and maintain it with a CE mark in mind, this course wi hep you evauate your software and processes so you can know what to do during the ife-cyce of your software to meet the Medica Device Directives and get on track. Medica Devices Utiizing Materias of Anima Origin: Practica Guidance on the Legisative Approva Process This one day course has been designed to provide manufacturers with the knowedge and skis to interpret the reguatory requirements reating to materias of anima origin, incuding those for which a TSE risk is expected. This course wi provide guidance on how to reduce risks and uncertainty in the EU reguatory process; gain an appreciation of typica hazards associated with anima tissues & derivatives; justifications needed to use these materias and awareness of common mistakes to avoid in sourcing, coection and handing to ensure deays are minimized. Book onine at medica.devices.bsigroup.com/training or ca +44 (0) BSI Medica Devices Training 5

6 Fast and experienced routes into goba markets. Be prepared In the competitive medica device market pace, ensuring that product deveopment meets a reguatory requirements is essentia. Understanding and consideration of the compicated cinica and reguatory requirements eary in the product ifecyce coud ensure your company gains the competitive advantage. Consoidated cinica and reguatory panning wi assist your company to maximise resources and minimise time to market. Wordwide access Our partnership approach offers a wide range of proven reguatory and quaity management programmes that work together for fu internationa compiance. Our QMS soutions incude: ISO 13485, ISO 9001, ISO and many more. BSI partner with internationa reguators to hep you get your products approved in the USA, Canada, Japan, Austraia, Hong Kong, Russia and Taiwan. CE marking: speed-to-market Cients work with us because we understand the chaenges medica device manufacturers face in getting compiant products to market quicky. CE-90 Standard: Our standard service, is competed within 90 days from submission, giving you predictabiity for accurate panning. CE- FastTrack: Our FastTrack programmes deiver the speedto-market you need to be competitive and move ahead of the competition. The aim is review competion in 45 days from submission with a choice of options: CE-45 Standard: 45 day service CE-Onsite: The review service is conducted at your premises, aowing for a faster time-ine and dynamic communication. CE-Dedicated: Your review wi be conducted remotey, your Product Expert wi be abe to arrange fexibe schedues with you. Seamess transfer to BSI If you decide to transfer your certification to BSI, we can offer a seamess exercise with comprehensive support and the absoute minimum eve of disruption. With expertise encompassing the fu range of industry sectors and management system standards. Certification support Throughout the certification process and beyond we can continuay hep you by providing: Expert training courses: In-house for your company Pubic courses, see website for the atest schedue On-ine, we have an increasing number of short courses running via distance earning Reguatory Updates, heping you pan for the future Free webinars Access to reevant standards. 6 BSI Medica Devices Training

7 Start your journey to business exceence, book your course now. Visit medicadevices.bsigroup.com/training or ca +44 (0) T: +44 (0) bsigroup.com BSI Medica Devices Training 7

8 Goba expertise Certification services ISO QMS Auditing CE marking Heath Canada CMDCAS Japan PAL FDA 510k Third-Party Review Programme FDA Accredited Persons Inspections Austraia EU CAB Hong Kong CAB Russian Registration Certification Taiwan TCP Training courses CE marking for AIMD, MDD and IVD ISO QMS Medica Devices Risk Management ISO CE marking Medica Devices with Software Compiing and Maintaining Technica Fies and Design Dossiers Cinica Evauation for Medica Devices Device - Drug Combinations: Practica Guidance on Borderine Issues and the Consutation Process Process Vaidation for the Medica Device industry Post Market Surveiance and Vigiance Medica Devices Utiising Materia of Anima Origin. Your partner in wordwide compiance: Ca BSI today on +44 (0) or visit medicadevices.bsigroup.com to start your partnership BSI Group - EMEA Kitemark Court, Davy Avenue, Knowhi, Miton Keynes MK5 8PP United Kingdom T:7 +44 (0) F:7 +44 (0) E:7 BSI Group - Germany BSI Group Deutschand GmbH Eastgate Hanauer Landstraße Frankfurt Germany T:7 +49 (0) F:7 +49 (0) E:7 BSI Group - Netherands Adam Smith Buiding T.R.Mathustraat 3c Amsterdam 1066 JR The Netherands T:7 +31 (0) F:7 +31 (0) E:7 BSI Group America Inc Sunset His Road, Suite 200 Reston, VA USA T: / F: E: BSI Group Asia Pac BSI - Singapore 460 Aexandra Road # 08-01/01, PSA buiding Singapore T: F: E: Visit us onine at: medicadevices.bsigroup.com The trademarks in this materia (for exampe the BSI ogo or the word KITEMARK ) are registered and unregistered trademarks owned by The British Standards Institution in United Kingdom and certain other countries throughout the word. BSI Group BSI/UK/1643/MD/0113/en/BLD

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