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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


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.

Book now

Book now

We do not currently have dates confirmed for this course; please contact us to be informed when it is scheduled; or to discuss running this course on an in-house basis for your staff.

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...

  • AstraZeneca AB
  • Bespak
  • Biocompatibles UK Ltd
  • Cardinal Health
  • Cook Ireland Ltd
  • Covidien
  • Dyson
  • Elcam Medical ACAL
  • Eurofins Biolab Srl
  • Fresenius HemoCare Netherlands BV
  • Mentor Medical Systems B.V.
  • Novo Nordisk A/S
  • Omron Healthcare Europe BV
  • Pall Europe Limited
  • Q-Med AB
  • Renishaw plc
  • Rousselot
  • Smiths Medical International Limited
  • Smiths Medical International Ltd
  • Summit Medical Ltd
  • Synthes GmbH
  • Systagenix Wound Management
  • Terumo Aortic
  • University of Edinburgh
  • William Cook Europe ApS

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