Professional Training
4.7 (7 Reviews)

Biological Evaluation of Medical Devices

Length
2 days
Price
1,299 GBP 1,099 GBP
Next course start
16 September, 2024 See details
Course delivery
Virtual Classroom
Length
2 days
Price
1,299 GBP 1,099 GBP
Next course start
16 September, 2024 See details
Course delivery
Virtual Classroom
Leave your details so the provider can get in touch

Biological Evaluation of Medical Devices

The ISO 10993 series of standards covering biological evaluation of medical devices is well established and regulatory authorities worldwide expect compliance. In Europe, compliance with the standards is the easiest way to meet the essential product safety requirements of the MDR and understanding a risk management approach to biological safety is essential.

This seminar will provide key guidance on how to use the standards and successfully apply a risk management approach to the biological evaluation of medical devices. There will be plenty of time during the programme for interactive discussion with experts in this field.

Benefits of attending:

  • Understand biological risk management
  • Clarify the requirements of ISO 10993-1
  • Learn what endpoints need to be addressed in a biological risk assessment
  • Establish how much chemical characterisation is necessary
  • Hear the FDA’s approach to ISO 10993
  • Better understand Medical Device Directive (MDD) safety requirements vs the Medical Device Regulation (MDR) safety requirements
  • Know how extractables and leachables impact on medical device safety
  • Discuss the Japanese and Chinese requirements

Upcoming start dates

1 start date available

16 September, 2024

  • Virtual Classroom
  • Online
  • English

Request information - obligation free

Contact course provider

Fill out your details to find out more about Biological Evaluation of Medical Devices.

  Contact the provider

  Get more information

  Register your interest

Country *

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

Customer Outreach Award

customer-outreach-badge-2019

We believe that it should be easy for you to find and compare training courses. 

Our Customer Outreach Award is presented to trusted providers who are excellent at responding to enquiries, making your search quicker, more efficient and easier, too.

Reviews by course attendees

Average rating 4.7

Based on 7 reviews.
Reviews are published according to our review policy.
Write a review!
5/5
Anna G
08 Feb 2022

Excellent and very informative course

5/5
Anna G
08 Feb 2022

Excellent and very informative course

4/5
Sarah H
08 Feb 2022

the course was well presented and clear enough for a complete beginner to understand.

Ads