Presented by
Management Forum
Key guidance on how to use the ISO 10993 series of standards and successfully apply a risk management approach to the biological evaluation of medical devices. *Includes:* Interactive workshops and discussion sessions
8-9 Feb 2022 + 1 more date
The ISO 10993 series of standards covering biological evaluation of medical devices is well established and regulatory authorities worldwide expect compliance. In Europe, compliance with the standards is the easiest way to meet the essential product safety requirements of the MDR and understanding a risk management approach to biological safety is essential.
This seminar will provide key guidance on how to use the standards and successfully apply a risk management approach to the biological evaluation of medical devices. There will be plenty of time during the programme for interactive discussion with experts in this field.
Benefits of attending:
The event will be of particular importance to those in the medical device industry from the following departments:
It will also be of interest to regulatory authorities, Notified Bodies and CROs supporting the medical device industry.
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.
Janine Ingleby is a Senior Safety Assessor with Chorley Consulting. She holds a MSc in Global aquatic biodiversity and a BSc in Molecular biology and biotechnology, both from the University of Hull. She has over 10 years of regulatory and product safety experience within FMCG and the Fragrance industry. She also holds a Prince2 practitioner qualification in project management. Janine has a great depth of knowledge in the regulation of cosmetics and fragrances as well as having toxicological data analysis skills for use in risk assessments of medicines, medical devices, cosmetics and general products.
She is an experienced presenter with particular strengths in the regulatory and quality management aspects of the biological evaluation of medical devices.
8-9 Feb 2022
Classroom
London venue TBC
09:00-14:10 UK (London)
Course code 11633
Until 04 Jan
1-2 Aug 2022
Classroom
London venue TBC
09:00-14:10 UK (London)
Course code 11879
Until 27 Jun
I learned a lot from this course, the speakers were great and they encouraged questions from the attendees. The quiz summarized each part well. My overall opinion is very positive and I would recommend it to my colleagues.
Oct 31 2019
Avital Levertov 
Regulatory Affairs Manager, Elcam Medical ACAL
Oct 31 2019
It was a good course with good shared discussion about many topics and issues. The course material was well organized.
Elen Lasri
Regulatory Affairs Specialist, Elcam Medical ACAL
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