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.
New for 2019
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.
A certificate of attendance for professional development will be available to each participant who completes the seminar
Programme Day One
General principles of biological risk management
- Differences between toxicology and medical device toxicology
- The risk management process according to ISO 14971:2019
- How does ISO 10993 relate to ISO 14971?
- Explanation of structure and core contents of ISO 10993:2018
- Understanding the requirements of ISO 10993-1:2018
- How to navigate through the standard and find applicable sections
- What have we learned from the development of ISO 10993 over the years?
Interactive session: Hazardous situations
Reviewing existing data
- Identifying applicable end points
- Compiling relevant data
- Characterising toxicological hazard from literature review
- Using data on prior use
- Gap analysis – determining the sufficiency of existing datasets
- Developing a Biological Evaluation Plan
- Physical and chemical characterisation
- Qualitative vs quantitative evaluation of materials
- Establishing whether additional chemical characterisation is necessary
- Quantification of extractables and leachables
- Limitations of chemical characterisation techniques
- Understand the requirements – goalposts moving with 10993-18:2019
- Biological equivalence – what is it and when is it achieved?
Interactive session: Evaluating chemical data
Programme Day Two
Quantitative toxicological risk assessment (QTRA)
- Identifying situations in need of QTRA
- Use of ISO 10993-17:2002 and alternative approaches
- Principles of toxicological risk assessment
- The Threshold of Toxicological Concern (TTC)
- Identification of constituents of concern
- Structure activity software
- Risk assessments for constituents, extractables and leachables
- When is biological testing necessary? Identifying uncertainties
- In-vitro vs in-vivo testing
- When is in-vitro testing necessary?
- How to leverage in-vitro results
- Examining ISO 10993-2 animal welfare requirements
- Taking account of the strengths and weaknesses of in-vivo tests
- Developing a test plan
Interactive session: Gap analysis
Risk assessment and control
- Information needed for a risk assessment
- Criteria for risk acceptability
- Risk reduction strategies
- Judging whether the data is sufficient
- Biological Evaluation Reports
Interactive session: Risk reduction
- Post-market surveillance data and the biological evaluation profile
- Importance of the feedback loop
- High-profile issues found after CE marking – what lessons can be learned?
Interactive session: Risk review
Q & A discussion
Summary and conclusions
Mr Philip Clay,
Director, Principal Toxicologist ,
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.
Ms Janine Ingleby,
Senior Safety Assessor ,
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.
This seminar will be of importance to those in the medical device industry from the following departments:
- Regulatory affairs
- Product safety/toxicology
- Analytical chemistry
- Risk assessment and risk management
- Materials research and evaluation
It will be of particular interest to Regulatory Authorities, Notified Bodies and CROs regulating or supporting the medical device industry
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