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
18-19 May 2020
& 25-26 Nov 2020
GBP 1,499 1,299 *
EUR 2,099 1,819 *
USD 2,338 2,026 *
* When you book before 10 Apr
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.
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
MDD safety requirements
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.
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.
|18-19 May 2020|
|18-19 May 2020||Cavendish Hotel, London||GBP 1,499.00
+ VAT @ 20.00%
Until 10 Apr*
|25-26 Nov 2020|
|25-26 Nov 2020||Rembrandt Hotel, London||GBP 1,499.00
+ VAT @ 20.00%
|Online registration unavailable: this date is nearing full capacity; please call us on 020 7749 4730 to register.|
* Note the early booking discount cannot be combined with any other offers or promotional code