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2021 Dates TBC, Radisson Blu Edwardian Grafton Hotel

2-day course

Explore the key challenges surrounding biocompatibility for medical devices and how to overcome them

Course Overview

Within medical devices, biocompatibility assessments are essential in the early stages of development to ensure patient safety. Notified Bodies must see adequate data on biocompatibility to be sure the device is fit for purpose.  This course will provide you with a solid understanding of the principles behind crucial regulations and issues within biocompatibility.

Supported by a wealth of examples and two practical sessions, this course will give you an in-depth look at ISO 10993. Over two days, you will examine the biological evaluation process and will improve your understanding of testing end-points and testing alternatives. Delegates will also be provided with additional time to discuss the implications of Brexit.

What will you learn?


Key developments
Key developments

Understand how biocompatibility and biological safety have developed

ISO 10993
ISO 10993

Comprehend the core structure and content of ISO 10993

Categorising devices
Categorising devices

Learn how to categorise devices for biological evaluations


Annex A.1
Annex A.1

Understand how to use the Annex A.1 table to identify end-points

In-vivo testing
In-vivo testing

Consider when in-vivo testing may be necessary

Sterilisation
Sterilisation

Review sterilisation options


Global regulations
Global regulations

Investigate global requirements

The new Medical Device Regulation (MDR)
The new Medical Device Regulation (MDR)

Discuss impacts of the new MDR

Who is this course for?

This course will be useful for anyone new to biocompatibility for medical devices, or who would like a refresher of this material, including:

  • Regulatory Affairs
  • Quality Assurance
  • Manufacturing, development and design
  • Toxicology
  • Process development

CPD Certified

Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age or educational level. This course has been assessed and is CPD certified.

25% discount on Routledge books

As a student on the course you will receive a 25% discount on any Routledge books or eBooks. To view the full product range visit the Routledge website www.routledge.com.

Examples of books and eBooks within medical devices include:

  • ISO 13485:2016: A Complete Guide to Quality Management in the Medical Device Industry, Second Edition
  • ISO 9001: 2015 - A Complete Guide to Quality Management Systems
  • Medical Device Quality Assurance and Regulatory Compliance
  • Design Controls for the Medical Device Industry, Third Edition
  • And more