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Biological Evaluation of Medical Devices Training Course

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

23-24 Mar 2023

& 18-19 Sep 2023

Book or reserve now

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.

Rona Middlemiss (More...)

Rona is a Senior Safety Assessor with Chorley Consulting. She holds a first class MSci in Biomedical Sciences from the University of Aberdeen. Additionally, she has attended training courses on the Practical Application of Toxicology in Drug Development and also Personal Animal License Course, Modules 1-3. She spent her year industry with a multinational consumer healthcare and medical device manufacturer, gaining experience in the safety assessment of medical devices. She joins Chorley from a Scientist role with British American Tobacco where she honed her toxicology skills performing toxicological risk assessment for harm reduction products. Rona brings to Chorley experience gained with a healthcare medical device manufacturer as well toxicological risk assessment skills gained during her time with BAT.

During her time with Chorley, Rona has rapidly developed her skills in performing toxicological risk assessments of extractable and leachable data including the use of in silico tools for the prediction of toxicological effects. She has also developed her presentation skills, having presented a number of on-line training modules around various aspects of Biological Evaluation of Medical Devices.

Book now

Book or reserve now

NEW higher discounts for booking multiple places - bring your colleagues to make your training budget go further:
30% off the 2nd delegate; 40% off the 3rd delegate; 50% off the 4th delegate

Choose your date below - or reserve your place with no obligation for 7 days at ipi.academy: Reserve now
23-24 Mar 2023
Face-to-face, Rembrandt Hotel London
09:00-17:00
UK (London)
23-24 Mar 2023
Face-to-face
Rembrandt Hotel London
09:00-17:00
UK (London)
GBP 1,499 1,299
EUR 2,149 1,869
USD 2,449 2,137
Until 16 Feb 23*
Enrol now
to attend Face-to-face
Rembrandt Hotel London
  • 2 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy
18-19 Sep 2023
Face-to-face, Rembrandt Hotel London
09:00-17:00
UK (London)
18-19 Sep 2023
Face-to-face
Rembrandt Hotel London
09:00-17:00
UK (London)
GBP 1,499 1,299
EUR 2,149 1,869
USD 2,449 2,137
Until 14 Aug 23*
Enrol now
to attend Face-to-face
Rembrandt Hotel London
  • 2 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.

Continuing professional development

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

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

Previous customers include...

  • Altomed
  • Angiomed GmbH & Co
  • AstraZeneca
  • AstraZeneca AB
  • Biocompatibles UK Ltd
  • BioTop Medical
  • Cook Ireland Ltd
  • Denish Medical Devices Cert.
  • Dyson
  • Elcam Medical ACAL
  • ITL LIMITED
  • LAB Research (Scantox)
  • Medigen Regulatory Limited
  • Merck Sharp & Dohme
  • MET Limited
  • Novo Nordisk A/S
  • Q-Med AB
  • RCC LTD
  • Renishaw plc
  • Rousselot
  • Russell Square Quality Associates Limited
  • SCHOTT Schweiz AG
  • Smith & Nephew Wound Management
  • Smiths Medical International Limited
  • Smiths Medical International Ltd
  • Sphere Medical Ltd
  • Terumo Aortic
  • University of Edinburgh
  • Vernacare
  • Xiros Ltd

Excellent and very informative course

Anna Gabbott, Regulatory Affairs Specialist, Vernacare, Feb 22

the course was well presented and clear enough for a complete beginner to understand.

Sarah Hinchliffe, Microbiology Manager, Xiros Ltd, Feb 22

Very detailed content and patient presenters

Elena Couzens, Service Development Manager, MET Limited, Feb 22

Very informative but also personalised

Paul Fineran, Healthcare Technology Portfolio Project and Development Manager, University of Edinburgh, Feb 22

Excellent and very informative course

Anna Gabbott, Regulatory Affairs Specialist, Vernacare, Feb 22

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