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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

Customised in-house training course

The content, presenters and format of this course are customised to your requirements.

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Details

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

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

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

Presenters

Philip Clay (More...)

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 (More...)

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.

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Customise & book

This course can be customised to meet your requirements, and delivered to your colleagues at your location or online. For more information, call us on +44 (0)20 7749 4730, email us at inhouse@management-forum.co.uk or contact us below:

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Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Training options

Public course dates

We can deliver and customise this course for any number of attendees, at your location or online. But if you have fewer colleagues, this course is running publically on:

  • 8-9 Feb 2022
  • 1-2 Aug 2022

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Previous customers include...

  • ABBOTT IRELAND
  • Allergan Medical
  • Angiomed GmbH & Co
  • AstraZeneca
  • AstraZeneca AB
  • BAUSCH & LOMB INC
  • Bespak
  • Biocompatibles UK Ltd
  • Cardinal Health
  • Cook Ireland Ltd
  • Covidien
  • Denish Medical Devices Cert.
  • DEPUY
  • Elcam Medical ACAL
  • Eurofins Biolab Srl
  • Fresenius HemoCare Netherlands BV
  • LAB Research (Scantox)
  • Merck Sharp & Dohme
  • Novo Nordisk A/S
  • Q-Med AB
  • SCHOTT Schweiz AG
  • Smith & Nephew Wound Management
  • Smiths Medical International Limited
  • Smiths Medical International Ltd
  • Summit Medical Ltd
  • Synthes GmbH
  • Systagenix Wound Management
  • Tissue Science Laboratories PLC
  • Wellspect Healthcare
  • ZAFA PHARMACEUTICALS (PVT) LTD

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, Oct 19

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.

Avital Levertov, Regulatory Affairs Manager, Elcam Medical ACAL, Oct 19