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?
Understand how biocompatibility and biological safety have developed
Comprehend the core structure and content of ISO 10993
Learn how to categorise devices for biological evaluations
Understand how to use the Annex A.1 table to identify end-points
Consider when in-vivo testing may be necessary
Review sterilisation options
Investigate global requirements
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
- Process development
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