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Phil Clay
Director, ISO TC/194 Member at Chorley Consulting


Philip Clay is Director and principal toxicologist with Chorley Consulting. He is a UK and European registered toxicologist and specialises in safety assessment with over 30 years experience. He has published and presented widely in his expert field of genetic toxicology and also in the wider area of safety assessment. Chorley Consulting designs safety assessment programmes for medical devices and also provides toxicological advice for a range of product types. Philip is presently a BSI committee member for CH/194 (Biological evaluation of medical devices).

Chorley Consulting works with a number clients ranging from multinational manufacturers to single product start-ups.  We have experience with assessing the biological safety of a wide range of devices including cosmetic surgery products, surgical implants, anaesthetic gas devices, catheters and invasive patient monitoring systems as well consumer healthcare products ranging from Class 3 devices down to Class 1.  Our biological safety assessments have formed part of technical file submissions to a number of notified bodies without comment as well as supporting clinical trial applications.  We also have experience with medical device submissions to regulatory authorities around the world including US FDA and China NMPA.

Agenda Sessions

  • Extractables and Leachables Testing a – Toxicologists Perspective