Following on from being the first EU notified body in the world to achieve designation to the Medical Devices Regulation, BSI was informed on 6 November by the Dutch Ministry of Health (VWS) that its Netherlands notified body is also now designated to the new MDR (EU 2017/745). Watch the video below to learn more.

Henry Sibun has over 20 years' experience in providing training and lecturing. Links to download corrigenda for the MDR and IVDR respectively: The standard can be purchased from BSI here: http://www.bsigroup.com/en-GB/about -b

Information Management. Environmental Management and Sustainability. Energy Management ISO 50001 training courses. This course will focus on the overall requirements of MDR, and not on specific devices or implementation issues.

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Related training . IVDR courses. Please refer to our 3-day-course for implementation of the MDR. Clinical evaluation and risk management. MDD to MDR transition course. Kevin Madden - Team Training Lead and Technical Team Manager, Orthopaedic & Dental Devices, Regulatory Services Kevin Madden is a Team Training Lead and Technical Team Manager with the Medical Devices Regulatory Services Team at BSI, which he joined in 2015.

As regulations change in the medical devices industry, the BSI Training Academy is supporting clients with a range of courses on MDR, IVDR and ISO 13485 to help navigate the new requirements. Read

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29 Oct 2019 Join R&Q's VP of EU MDR and IVDR Consulting Services in Learning Objective: At the conclusion of this session, the participant should be able to: experience in the medical device industry, including 21 year

Medical Devices. Information Security. Information Management. Environmental Management and Sustainability. Energy Management ISO 50001 training courses. 2017-08-21 · BSI has created a guide to help you to map the MDR Safety and Performance Requirements (SPRs) to the Essential Requirements of the Medical Devices Directive (MDD), and the Active Implantable Medical Devices Directive (AIMDD). The document also lists other relevant information which can help you in planning your transition to the MDR. This BSI Group presentation covers technical document requirements under the European Medical Device Regulation (MDR).

Online or classroom options. Learn about upcoming changes and how they affect you. European Commission (EC) Documents TOPIC Title Author MD Manufacturers Factsheet for Manufacturers of Medical Devices EC Implementation Model for Medical Devices Regulation Step by Step Guide EC MDCG 2019-15 GUIDANCE NOTES FOR MANUFACTURERS OF CLASS I MEDICAL DEVICES EC IVD Manufacturers step by step Implementation Model for In-Vitro Diagnostic Medical Devices Regulation Step by Step […] Learn about the requirements for technical documentation under the MDR with this excerpt of Monisha Phillips’ (Global Head, Orthopaedic and Dental, BSI Group TRAINING, BASED ON EU MDR AND MDSAP 3-5 days | Instructor-led / On-site Students will gain valuable knowledge on how to prepare for the upcoming changes from the MDD to the MDR. Students will learn how to audit program management to include preparation of internal audit plans and how to address gaps during the audit. This course will also focus on MDR Training Resources – Regulation 745/2017 on Medical Devices: main changes and timeline to implementation – Regulation 745/2017 on Medical Devices: obligations of the economic operators, from Eudamed registration to Responsible person – Regulation 745/2017 on Medical Devices: Unique Device Identification – Regulation 745/2017 on Medical Devices: Technical File structure Medical Device Coordination Group provides guidance notes for manufacturers of class I devices. Even with the postponement of the date of application for the Medical Devices Regulation to 26 May 2021, manufacturers still need to pay attention to devices for which there are no transitional provisions. Gain insight into the classification rules under the MDR with this excerpt of Monisha Phillips’ (Global Head, Orthopaedic and Dental, BSI Group) talk at the Technical Documentation to Comply with the MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Regulation) Training Course This seminar will provide essential guidance on the content of the technical documentation file, the changes required and the practicalities of compiling and maintaining the technical file to comply with the MDR and IVDR.
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Medical Device Directive (MDD) to Medical Device Regulation (MDR) IVD Directive (IVDD) to IVD Regulation (IVDR) Transition; Requirements of the Medical Device Regulation (MDR) for CE Marking Following on from being the first EU notified body in the world to achieve designation to the Medical Devices Regulation, BSI was informed on 6 November by the Dutch Ministry of Health (VWS) that its Netherlands notified body is also now designated to the new MDR (EU 2017/745). Watch the video below to learn more. On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate. Prerequisites Participants must have a good understanding of the requirements in the MDR, which is conveyed by our 1 day Requirements course or our MDD to MDR transition course.

Watch the video below to learn more. Courses by subject. Business Continuity Management. ISO 45001 Occupational Health and Safety.
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Our one day training course has been designed to introduce medical device manufacturers and other Economic Operators in the supply chain to the key changes to requirements for CE marking following the publication of the new Medical Devices Regulation (MDR).

Information Management. Environmental Management and Sustainability.

Training: 4 & 5 June 2018 Location: Universität Basel / Kollegienhaus in Basel, Switzerland Language: English Price: €750,- for 1 day or €950,- for 2 days. Introduction Qserve has designed together with BSI a 2-day high profile workshop program to assist in determining the crucial steps needed for your organization.

Watch the video below to learn more.

Training in Armed and Unarmed Security Guard MDR and IVDR Publications The new Medical Device & In-vitro Medical Device Regulations are now available in the Official Journal, having being published as: Regulation (EU) 2017/745 Of The European Parliament and of the Council of 5th April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90 Learn about assessment and certification under the MDR with this Compliance Navigator video featuring BSI’s Monisha Phillips at the Med-Tech Innovation Expo 2019-07-15 · But notified body BSI Group has followed a different path. BSI was the first to be designated under the new MDR regulation in January 2019, and it expects to be designated in September in the Netherlands. Gary Slack is BSI Group's senior vice president of medical devices. Slack, who's been with BSI since 2008, has worked in the industry since 1994. The MDR & IVDR EU Workshop is dedicated to guidance and training for those impacted by the new Regulations! The The EU MDR regulation applies from 26 May 2020 – with significant UDI requirements, some of which are new and different from the US regulation. Training: 4 & 5 June 2018 Location: Universität Basel / Kollegienhaus in Basel, Switzerland Language: English Price: €750,- for 1 day or €950,- for 2 days.