Course description
Biocompatibility assessments are an essential part of submissions to regulatory agencies for medical devices. 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.
Do you work at this organisation and want to update this page?
Is there out-of-date information about your organisation or courses published here? Fill out this form to get in touch with us.
Suitability - Who should attend?
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
Training Course Content
- 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
- Examine materials characterisation
- Consider when in-vivo testing may be necessary
- Review sterilisation options
- Investigate global requirements
Why choose PTI
On average, delegates of their online academies said:
Quality of content:
4/5
85% had applied content during the course to their role
Delivery rating:
4/5
Reviews
Average rating 5
The course provided full knowledge on the topic, also covered all of ISO 10993 and international aspects.
I enjoyed getting a better understanding of the requirements through the workshop!