[WEBINAR] Demonstrate the Biological Safety of your Medical Devices in a compliant yet pragmatic way

July 20, 2021
|In Product Development
|By Léa Jamelot

Biocompatibility of medical devices is a critical and evolving subject. As soon as a device has any direct or indirect tissue contact, FDA and other authorities will need biocompatibility information in the submission.

 

But what is exactly Biocompatibility?
What aspects of biological risks should one think of?
Is it mandatory to execute all the tests recommended in the annex of ISO 10993-1?
Where can one find relevant data to show biological safety-related evidence of medical devices?
When is the right moment for testing my device/prototype?

 

In order to avoid delays in the development and approval process, it is important to understand the full biocompatibility workflow needed for each unique device. During this on-demand webinar, let you guide by our expert DR Adrien Marchand through the Biocompatibility Workflow, including:

  • The basic concepts of Biocompatibility
  • The development of the Biological Evaluation Plan as per ISO 10993-1
  • The importance of device classification based on duration and type of patient contact
  • The considerations and identification of biological risks
  • The source of biological safety-related evidence
  • The importance and nature of Chemical Characterization
  • The appropriate tests to conduct
  • The challenges you need to know

 

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