This seminar will provide essential guidance on how to undertake a successful conformity assessment process and subsequently apply (or continue to apply) the CE mark
29-30 Sep 2020
This course will show you how to plan for and undertake the conformity assessment process for your medical device to demonstrate that your product meets the enhanced requirements of the new Medical Devices Regulation (MDR).
As with the current Directive, the choice of conformity assessment route depends on the classification of the device. Once you have undergone a valid conformity assessment process and shown that your device has met the new requirements, you will be in a position to place a CE mark on your product which is your access to the European market.
The programme will provide essential guidance on how to undertake a successful conformity assessment process and subsequently
apply (or continue to apply) the CE mark. The importance of quality management systems, risk management, the use of standards and the current status of implementing acts, common specifications and published guidance will be a particular focus. This is
an excellent opportunity to understand the requirements and regulations and to discuss the complexities with two experts in this field.
Medical device regulatory affairs professionals
Overview of the new MDR requirements
The CE marking process under the MDR
Deciding on the most appropriate assessment route for your product
Conformity assessment route workshop
Notified Bodies under the MDR and the role of Competent Authorities
Demonstrating compliance with harmonised standards
Quality management systems (QMS) and risk management workshop
Feedback and discussion
Feedback and discussion
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.
Paul is a member of the Association of British Healthcare Industries (ABHI) Technical Policy Group and is Convenor of the ABHI ISO TC 210 Mirror Group. Convenor of the BSI Committee, which monitors all of the work undertaken by ISO TC 210, and Convenor of the BSI Sub-committee dealing with Quality Systems. As UK Delegation Leader to ISO TC 210, Paul is also actively involved in the work of national, European and international standards’ committees, dealing with revisions to the ISO 9000 series, ISO 13485, ISO 14971, ISO 15223 and others. He is Deputy Chairman and Council Member of Barema (British Anaesthetic & Respiratory Manufacturers Association), also a Member of the Association of Anaesthetists of Great Britain and Ireland (AAGBI) Safety Committee.