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UK Medical Device Regulations after Brexit
June 11, 2020 @ 9:00 am - 10:00 am$10.00 – $25
UK Medical Device Regulations after Brexit.
What Scenarios to Plan for?
9:00 am – 10:00 am
1 hour towards your RAC certification
Program Manager: Shepard G. Bentley, RAC, Global Regulatory Consultant
Mr. Barry Fitch, Head of RAQA at Combat Medical Ltd, Wheathampstead, UK
Mr. Shep Bentley, RAC, Founder of Bentley Biomedical Consulting, Laguna Niguel, CA
The UK regulatory body for Medical Devices, MHRA, has been very actively involved in shaping the EU’s new Medical device Regulations (MDR). As Brexit is now a reality, and as the political winds in the UK are driving towards more, rather than less independence from Europe, one can legitimately ask what could happen after Dec 31st, when EU law ceases to apply in the UK.
During this talk we would like to explore possible scenarios.
OCRA Members: $25
Non-Members: $100, includes 1-year OCRA membership (Purchase Membership First)
Government and Student Members: $10, with student/government ID
Barry Fitch, Head of RAQA at Combat Medical Ltd
Barry has over 40 years’ experience working in industry firstly in the aerospace/military sector and then for the past 30 plus years in the Medical Device, IVD and Certification sectors. He has held Management positions in Manufacturing, Quality Assurance and Regulatory Affairs at Graseby/Smiths Medical, Swiss Precision Diagnostics GmBH, DNA Electronics and Combat Medical Ltd working with a variety of Medical and IVD devices
After leaving Graseby he spent 6 years at UL International (UK) Ltd, one of the UK Notified Bodies designated under both the Medical Device and IVD Directives performing assessments of Technical Documentation and Management Systems audits against the requirements of MDD, CMDr and ISO13485. Additionally he has experience of product safety assessments against the requirements of IEC 60601-1 2nd Edition and IEC61010
Barry then spent 2 years as the Quality Assurance Manager for Swiss Precision Diagnostics R & D facility in Bedford, an IVD manufacturer of the “Clearblue” brand of OTC pregnancy and ovulation testing devices as the Manag
ement Representative and responsible for a Team of Design Compliance engineers and the Quality Systems team
In May 2014 he moved to AMTAC (Intertek) as Head of Notified Body and in April 2017 moved to DNA Electronics as QA RA Manager in their London facility working in the Next Generation Sequencing area
Currently he is the Head of RAQA at Combat Medical Ltd in the UK with overall responsibility for both their UK and Spanish facilities regulatory and quality strategy
He has delivered training courses on the EU Regulatory system and specifically the MDD to the Saudi FDA, Malaysian Ministry of Health, presented at conferences on subjects such as electronic Instructions for use and lectured at Cranfield University on changes to the MDD, and Medical Device Classification and developed internal and public courses covering the MDR for AMTAC.
He has qualifications in Mechanical Production Engineering, Electronics and is a Member of the Chartered Management Institute in the UK.
Shep Bentley, RAC, Founder of Bentley Biomedical Consulting
Shep Bentley is a
regulatory affairs professional who leads a team with diverse talents, qualifications and cultural backgrounds to enable unconventional results at competitive rates.
A student of literature, law and medicine with a knack for languages and debating, he has a passion for championing new ideas and approaches to the age old problems of health care to regulators.
He and his team are resourceful, perpetually inquisitive and dissatisfied with the more burdensome approaches to portraying safety and effectiveness to the government. Their combined education spans the range of life sciences through the doctoral level. Shep retired from the reserve of the U.S. Marine Corps as a Lieutenant Colonel in 2005, after having served in Iraq. He is dedicated to the advancement of the life sciences.
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