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 will be the easiest way to meet the relevant essential product safety requirements of the Medical Device Regulation. Understanding a risk management approach to biological evaluation 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 for interactive discussion with experts in this field.
This seminar will be of importance to those in the medical device industry from the following departments:
An introduction to medical devices
An introduction to biocompatibility
Biocompatibility vs biological safety
ISO 10993 history and development
ISO 10993 structure and content
ISO/TR 15499 and 10993/1 (2018)
Relationship between 10993 and 14971
Medical device categorisation for biological risk assessment
The move away from in vivo testing
Endpoints to be addressed in a biological risk assessment
Chemical characterisation vs chemical information
Guidance on technical aspects of specific biocompatibility tests
Extractables and leachables testing – when and why?
Risk assessment using E&L data
Medical Device Directive (MDD) safety requirements
Medical Device Regulation (MDR) safety requirements
Good Laboratory Practice (GLP)
The 510(K) process
FDA’s take on ISO 10993
MDR – gap analysis of existing data
Change management – impact on biological risk assessment
Questions and final discussion
Interactive workshops and discussion sessions will take place throughout the two days
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.