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Biocompatibility assessment of medical devices in 4 steps - FDA recommendations

Biological assessment or testing of the biocompatibility of medical devices is an essential part of conformity assessment. But how do I properly and efficiently assess the biocompatibility of my medical device? The FDA has published new recommendations for assessing the biocompatibility of medical devices.

Tags: Biocompatibilty, FDA, medical device

Procedure for assessing the biocompatibility of a medical device:

Step 1

Basics of biocompatibility:
Glossary of biocompatibility terms

Step 2

Biocompatibility Evaluation Endpoint Tables:

Step 3

Test Article - Documenting How a Test Article Compares to the Proposed Medical Device - read more

Step 4

Test report - What Should I Put in a Test Report?

  • Test reports
  • Test article preparation
  • Test parameters and acceptance criteria
  • Analysis of results
  • Conclusions

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