Content - Medical Qualification Support

Medical Qualification Support

With unequaled experience, Mikron is the partner best suited to assist you – from design and approval to the end of your product’s life cycle. We offer a full range of consulting services and are committed to ensuring that the final result exceeds your expectations.

Your benefits

  • Documentation harmonized for the United States, European and Asian markets.
  • The documents provided are approved and ready for use during the next stage of qualification.
  • The basic machine – hardware and software – has been pre-validated according to GAM P 5 and is 21 CFR part 11 compatible. Over 150 tests have already been successfully tested on your machine, and new tests can focus on the quality-critical system elements.
  • The experts at Mikron are at your side for each step in the project. There is therefore no need to engage an external consultancy.
  • 100 years of experience in manufacturing high-quality machinery.

Qualification process