Services provided:

Guidance and industry training.

  • Guidance on 601 family of standard requirements through the development process, starting from the early stages and ending with the compliance testing stage.
  • Training for the engineering and quality assurance/regulatory teams on standards and hands on testing, including Production Line testing.
  • Review of Risk Management File.
  • Review of User manual and labeling.
  • Support in preparation of test plan for EMC testing and integration with Safety.

 

Pre-compliance and engineering testing.

  • Pre-compliance testing during development process.
  • Engineering testing

 

Check-Up service.

  • Check-Up for the Helsinki committee (Testing before the clinical trials).

 

Full compliance testing.

  • Full compliance testing towards various standards from 601 family.
  • Testing of Medical Lasers.
  • Testing of Light sources with medical purposes.
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