Phase 5: Signed and Sealed

Our development team accompanies your product until final certification. In this phase we prepare the second part of the product file within the scope of the conformity process, which means:

• Mechanical component review
• Evaluation of the manufacturing process
• Clinical evaluation

Certification occurs via the notified body, MedCert GmbH. Our specialists of the Regulatory Affairs division maintain their perspective, react to the required adjustments and changes.

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