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.

9-10 Apr 2019

& 2-3 Oct 2019

GBP 1,499 1,299 *
EUR 2,099 1,819 *
USD 2,338 2,026 *
* When you book before 15 Feb

Book now

Course overview

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.

Who should attend?

This seminar will be of 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 be of particular interest to Regulatory Authorities, Notified Bodies and CROs regulating or supporting the medical device industry

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

Materials characterisation

  • 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

Biological testing

  • 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

Risk review

  • 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

Presenters

Jeremy Tinkler (9-10 Apr 2019)

Jeremy Tinkler, Director, Regulatory Consultancy & QA, MedPass International. His responsibilities include; regulatory & clinical strategy, adverse event assessment & reporting, regulatory consultancy (strategic planning, clinical evaluation, biocompatibility assessment, risk analysis, etc.). He is a member of the European Commission Working Group on Clinical Investigation & Evaluation and has overall management of ISO 13485 QMS.

From 1987-2007, he was with the MHRA (UK Competent Authority) as Principal Specialist, Biosciences & Implants. His responsibilities there included direction of safety assessments, e.g.clinical investigation notifications and adverse incident investigation. He is also experienced in the following areas: tissue engineering, emerging technologies, drug-device combinations, animal tissues, wound care/closure products, cardiovascular, plastic surgery, ophthalmic, orthopaedic implants, biocompatibility, risk management, compliance assessment, quality/NB audit, product evaluation, research commissioning and borderline classification.

He takes a leading role in standards development, at national and international level and is Chairman of ISO/TC 194 (which develops ISO 10993 & 14155). He is also a European Registered Toxicologist. He has 10 years experience as a toxicologist, Study Director or Senior Scientist in toxicology laboratories and the Health and Safety Executive. Jeremy managed MHRA’s device toxicology activities 1987-2007 and he is a Lecturer at the University of Surrey and Queen Mary, MSc.

Michelle Kelly (9-10 Apr 2019)

Michelle Kelly is Biological Safety Manager for MHRA devices. She has worked for the agency since 2008 and current responsibilities include principal lead on all clinical trial applications for biological safety, provide expert biological safety advice and direction to the regulatory and safety and surveillance teams on compliance, vigilance and Notified Body matters. Michelle also works with key stakeholders towards the development of international standards to help innovation to the UK market. She is currently the chair of CH/194, a committee responsible for the UK input to ISO/TC 194 and CEN/TC 206 for standards relating to biological evaluation of medical devices. Michelle has a BSc in Biomedical and Advanced Materials from University of Limerick in Ireland, and an MSc in Applied Toxicology from University of Surrey achieving the top mark in both programmes of study.

Book now

9-10 Apr 2019
9-10 Apr 2019 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 15 Feb
Enrol now
2-3 Oct 2019
2-3 Oct 2019 Cavendish Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now

Previous customers include...

  • ABBOTT IRELAND
  • Allergan Medical
  • Angiomed GmbH & Co
  • AstraZeneca AB
  • BAUSCH & LOMB INC
  • Bespak
  • Biocompatibles UK Ltd
  • Cardinal Health
  • Cook Ireland Ltd
  • Covidien
  • Denish Medical Devices Cert.
  • Eurofins Biolab Srl
  • Mentor Medical Systems B.V.
  • Merck Sharp & Dohme
  • Omron Healthcare Europe BV
  • Pall Europe Limited
  • Q-Med AB
  • RCC LTD
  • Renishaw plc
  • Russell Square Quality Associates Limited
  • Smith & Nephew Wound Management
  • Smiths Medical International Limited
  • Smiths Medical International Ltd
  • Sphere Medical Ltd
  • Synthes GmbH
  • Systagenix Wound Management
  • Tissue Science Laboratories PLC
  • Wellspect Healthcare
  • William Cook Europe ApS
  • ZAFA PHARMACEUTICALS (PVT) LTD