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Regulatory Affairs

Mechanical testing - planning and evaluation

The mechanical safety of a medical device must be demonstrated via preclinical mechanical testing. For planning and evaluation of the test results, the following questions have to be answered:

 

  • Which tests are to be performed?     
  • Are standard test procedures applicable or do individual test procedures have to be developed?
  • How does an individual test procedure have to be structured so that it provides valid results?
  • What should be the number of samples per test (sample size)?
  • With which implant sizes should the tests be performed and how can the worst case size be defined?
  • How do the mechanical test results have to be interpreted?
  • Where are the acceptance criteria?
  • Does the implant meet the individual mechanical requirements?

 

With over 10 years of experiences and based on our close connection to science we will be happy to support you in answering these or other questions related to mechanical medical device testing.

 

Meet our experts at experts@spineserv.de or by phone at +49 731 3885 1946.