Biological Evaluation of Medical Devices: Key Guidance on How to Use the ISO 10993 Series of Standards (London, United Kingdom - May 27-28, 2020)

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Oct 31, 2019, 06:15 ET

DUBLIN, Oct. 31, 2019 /PRNewswire/ -- The "Biological Evaluation of Medical Devices" conference has been added to ResearchAndMarkets.com's offering.

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

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

Agenda:

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

For more information about this conference visit https://www.researchandmarkets.com/r/4zk6kt

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