Biological Evaluation of Medical Devices

Philip Clay

Philip Clay is Director and principal toxicologist with Chorley Consulting. He is a UK and European registered toxicologist and specialises in product safety assessment with over 30 years’ experience in toxicology and safety assessment. He is a BSI committee member on CH/194 (Biological evaluation of medical devices) and Principal Expert for WG6 (Mutagenicity, carcinogenicity and reproductive toxicity).
Philip established his reputation as a genetic toxicologist working within the agrochemical, chemical and pharmaceutical industries. He has contributed to many expert panels, helping to shape the testing guidelines and strategies in place today. More recently, this experience and depth of understanding has been applied to designing safety assessment programmes for medical devices and consumer healthcare products for a wide range of clients. Philip is presently a member of a Consumer Healthcare Products Association (CHPA) expert group lobbying US FDA regarding the use of in vitro data in the assessment of the biocompatibility of medical devices.
He has extensive experience in the biological safety evaluation of a wide range of medical devices from Class 1 consumer healthcare devices through to Class 3 implantable devices. He is an experienced speaker at scientific conferences and has delivered training on biological safety evaluation around the world.

Katherine Torrence

Katherine is a Senior Safety Assessor with Chorley Consulting. She holds a BSc in Biomedical Sciences and an MSc in Translational Oncology, both from the University of Hull. She has worked within the health sector in both the NHS and in industry for several years gaining product safety experience working with medicines and medical devices. She is an experienced MedDRA coder and is a skilled medical writer having attended training course on the writing of non clinical overviews for medicines. More recently, she has completed training courses on the biocompatibility of medical devices and has extensive experience in the assessing of biological safety of a range of medical devices. Alongside her knowledge of biocompatibility, she has attended training on EU MDR implementation and has prepared numerous biological safety assessments ready for MDR submission. Katherine brings to Chorley experience gained with a healthcare medical device manufacturer as well as literature and data searching and analysis skills for use in risk assessment of medicines, medical devices, cosmetics and general products.