Technical Director, Regulatory Affairs
QuidelOrtho, United Kingdom
Mr Richard Saunders (FIBMS) has over 30 years’ experience of International and European Quality and Regulatory Affairs in the in-Vitro Diagnostics medical device industry and currently is the Technical Director Regulatory Affairs at QuidelOrtho and is leading a project to bring them into compliance with the In-Vitro Diagnostics Regulation (2017/746).
In addition, Richard plays an active role in providing guidance and lobbying on new and revised legislation, primarily via the trade associations MedTech Europe and BIVDA (British In Vitro Diagnostics Association). He is an active member of the MedTech Europe Class D/Annex II List A Working Group, Clinical Evidence Working Group, Technical Forum Working Group and Labelling Working Group. He was chair of the BIVDA Regulatory Affairs Working Party for 5 years up until June 2022, and continues to play an active part in the national association.
Richard trained as a medical microbiologist, spending his first working years at St George’s Hospital Public Health Laboratories before starting in industry. His previous industry experience has been with Wellcome Diagnostics, Murex Biotech, Abbot Diagnostics and Abbott Diabetes Care. His roles have included quality control, quality assurance, compliance and regulatory affairs.
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Conformity Assessment of Class D Devices: What is the Current Status?
Thursday, May 11, 2023
16:45 – 17:45 CEST