Professional Training

The Fundamentals of Biocompatibility for Medical Devices

PTI, Online
Length
4 weeks
Length
4 weeks
Leave your details so the provider can get in touch

Course description

The ISO 10993 standards are used by medical device manufacturers for the evaluation of biological safety testing, and in late 2018 they were updated to adopt a more risk-based approach to biocompatibility testing.

Over four weeks this course will provide you with a baseline understanding of the key changes to ISO 10993 and what you need to include in an evaluation under the new requirements. In addition, you will be able understand biocompatibility in the context of risk management, the MDR safety requirements and from a global perspective, cemented by a series of case studies.

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Is there out-of-date information about your organisation or courses published here?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 and update their understanding of regulations, including:

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

Training Course Content

  • Understand the relationship between biocompatibility testing and ISO 14971
  • Analyse ISO 10993-1 and its updates
  • Explore material characterisation in its different forms
  • Examine the MDR safety requirements in the context of biocompatibility
  • Recognise the differences in the EU MDR and FDA 510(k) approaches
  • Review the relevant End Points for Consideration

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

Get Inspired! Watch the Video

Request info

Contact form

We are unable to connect you directly to this provider. However, our team will connect you to providers of similar courses if you fill out this form and select "Please recommend similar courses"
Country *

reCAPTCHA logo This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Ads