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 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.