Signed and Sealed

More and more customers entrust the certification process to us in addition to the development of a new product. We manage the entire conformity evaluation process as governed in the currently valid version of the European directive 93/42 EEC. Our specialists of the Regulatory Affairs division maintain their perspective, react to the required adjustments and changes. Yet another task which you can cross off from your to-do list!

Our service for your product certification:

• Performance of conformity methods according to 93/42/EEC
• Creation of a product file with proof of
  • Risk analysis
  • Mechanical component review
  • Evaluation of the manufacturing process
  • Clinical evaluation
• Certification via the notified MedCert
• Monitoring and approval by the department of Regulatory Affairs