Biological Evaluation of Medical Devices

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

Book now

Course overview

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:

  • Understand biological risk management
  • Clarify the requirements of ISO 10993-1
  • Learn what endpoints need to be addressed in a biological risk assessment
  • Establish how much chemical characterisation is necessary
  • Hear the FDA’s approach to ISO 10993
  • Better understand Medical Device Directive (MDD) safety requirements vs the Medical Device Regulation (MDR) safety requirements
  • Know how extractables and leachables impact on medical device safety
  • Discuss the Japanese and Chineserequirements

Who should attend?

The event will be of particular importance to those in the medical device industry from the following departments:

  • Regulatory affairs
  • R&D
  • Product safety/toxicology
  • Analytical chemistry
  • Risk assessment and risk management
  • Materials research and evaluation

It will also be of interest to regulatory authorities, Notified Bodies and CROs supporting the medical device industry.

Programme day one

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

Physical characterisation

Guidance on technical aspects of specific biocompatibility tests

Programme day two

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

Japanese requirements

Chinese requirements

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

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.

Book now

18-19 May 2020
18-19 May 2020 Cavendish Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 10 Apr*
Enrol now
25-26 Nov 2020
25-26 Nov 2020 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ 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

Previous customers include...

  • Allergan Medical
  • AstraZeneca AB
  • Bespak
  • BioTop Medical
  • Cardinal Health
  • Covidien
  • Denish Medical Devices Cert.
  • Depuy CMW
  • Fresenius HemoCare Netherlands BV
  • LAB Research (Scantox)
  • Mentor Medical Systems B.V.
  • Merck Sharp & Dohme
  • Novo Nordisk A/S
  • Omron Healthcare Europe BV
  • Pall Europe Limited
  • Q-Med AB
  • Renishaw plc
  • Russell Square Quality Associates Limited
  • Smith & Nephew Wound Management
  • Sphere Medical Ltd
  • Summit Medical Ltd
  • Synthes GmbH
  • Systagenix Wound Management
  • Tissue Science Laboratories PLC
  • Wellspect Healthcare
  • William Cook Europe ApS