A Guide to Data Sources and Literature Review During ISO 10993 Biological Evaluation

Watch Educo Life Science Trainer Rona Middlemiss

We interviewed Educo Life Sciences trainer Rona Middlemiss to discuss Biological Evaluation literature review and data sources. This area is critical as it is a requirement of all medical device categories as per ISO 10993. It aims are to assess the risk and benefits of a device and its materials and to identify what further data is required.

In the interview, Rona provides answers to the following questions:

  • Why is the use of data sources so important during biological evaluations?
  • What is the process of conducting a literature review?
  • When is this information used?
  • How do you identify relevant data sources?
  • What do you do when there is no data available?
  • What do you do with all the information?
  • What are the common pitfalls?


Watch the interview on biological evaluation literature review below. 


Learn more about the course Rona delivers on: Understanding Biocompatibility for Medical Devices

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