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.
★★★★★ "Very good and would recommend. Paul and Will both had very good knowledge of the MDR and complimente... more"
Before placing a medical device on the European market, manufacturers need to produce technical documentation providing evidence of conformity with the relevant legislation.
From the 26 May 2020, technical documentation needs to comply with the Medical Device Regulation (MDR) (EU) Regulation 2017/745. Manufacturers’ who already have products on the market under the MDD (Medical Device Directive) or AIMDD (Active Implantable Medical Device Directive) who wish to obtain or renew a CE certificate or issue a Declaration of Conformity (DoC), will eventually have to revise their technical documentation to comply with the MDR at the latest by 27 May 2024.
Furthermore, manufacturers of In-Vitro Diagnostic Devices will also need to revise their technical documentation to comply with the In-Vitro Diagnostic Regulation (IVDR) (EU) Regulation 2017/746 by the 26 May 2022.
The new MDR and IVDR impacts manufacturers, stakeholders, Competent Authorities (CAs) and Notified Bodies (NBs) on how the technical documentation should be developed and maintained. The requirements have been raised and will be subject to more scrutiny by the CA and NB.
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. Our expert trainers will guide you through the requirements and give you practical advice on how to manage the life cycle of the technical file.
Will Burton, Director of Russell Square Quality Representatives (RSQR) Ltd, is engaged in providing a range of consultancy and training services to the international medical device, pharmaceutical and biotechnology industry sectors. Prior to founding RSQA in 1995, Will was the Professional Services Manager of the Manufacturer Registration Scheme Business Unit of the UK Medical Devices Agency (now MHRA).
He is a Pharmacist, Medicinal Product Qualified Person, Medical Device Expert and registered international lead assessor. He managed the UK team of medical device expert assessors performing worldwide quality systems audits of medical device manufacturers against the requirements of the Department of Health’s Quality Systems Documents which formed the foundation for ISO 13485. He has very extensive auditing and quality systems experience and was closely involved in the selection, training and monitoring of UK Notified Bodies. He continues to perform QMS audits to ISO 13485 worldwide and has lectured internationally on related topics.
Paul Sim, Regulatory Affairs Manager, BSi Group. Paul has worked in the healthcare industry for 34 years and is currently Project Managing BSI’s implementation of EU Commission Recommendation 2013/473/EU dealing with Unannounced Audits. Joining BSI in August 2010 leading the BSI effort working with the Saudi Food & Drug Authority on the implementation of the SFDA Medical Device Interim Regulations.
Previously he held senior RAQA leadership positions at Spacelabs Healthcare, Teleflex Medical, Smiths Medical, Ohmeda (formerly The BOC Group healthcare business)
Medical Device experience is across a very broad range of devices including: anaesthesia systems, patient monitors, vapourisers, ventilators, breathing circuits, single use sterile disposables and devices for re-use, infant warmers, incubators, steralisers, autoclaves, operating tables, infusion pumps and associated disposables, urinary catheters, surgical instruments, diagnostic cardiology etc.
Very good and would recommend. Paul and Will both had very good knowledge of the MDR and complimented each other very well. Paul and Will also took time to answer individual questions.
May 8 2019
Regulatory Affairs Specialist, Presspart
May 8 2019
Very good speaks with a lot of experience.
Regulatory Affairs Officer , Halyard Belgium BVBA (Avanos)
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training expert Aleksandra Beer to discuss your requirements:
Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to: