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Biocompatibility of Medical Devices

This course covers the Biocompatibility of Medical Devices. By the end of this course, participants will have a strong foundational knowledge of the importance of biocompatibility in the manufacture of medical devices.

Course Details

The aims and learning outcomes of this course are:

  • To understand the ISO 10993 Biocompatibility Standard.
  • To understand the classification of devices and their characteristics. 
  • To understand biocompatibility testing routes.

Following completion of this course, participants should:

  • Have a good working knowledge of the importance of biocompatibility and its importance in the manufacture of medical devices.
  • Understand the processes within a Biological Evaluation Plan and how to integrate them into the Technical Documentation.
  • Recognise, and characterise, materials used in a medical device.
  • Understand key concepts such as sample numbers, cytotoxicity, sensitisation and irritation, and other key biological tests. 

This is a two day course in which participants will fully engage with the lecturer through group and individual exercises.  There are plenty of opportunities to ask questions and the course can be fully tailored to the company’s products and internal structure. 

This course explores biocompatibility and is broken down into three modules, covering the following key areas:

  1. Characterisation of devices.
  2. Classification of devices.
  3. Biocompatibility testing.