Explore the key challenges surrounding biocompatibility for medical devices and how to overcome them
Course Overview
在医疗设备,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.
支持大量的例子和两个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 websitewww.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
