Your Products in compliance around the world
Your Products in compliance around the world

          Register Medical Devices

Services guide...

 

CE MARK AND ACCESS TO THE MARKET

process

  • 1. The product compliance must be ensured
  • 2. The product must be classified
  • 3. Technical File elaboration.
    • Essential requirements.
    • Processes Validation.
    • Clinic Evaluation.
    • Laboratory test verification.
    • Risk management.
  • 3. A Notified Body must be involved (for products other than class I) and the technical file including the Declaration of Conformity must be prepared.
  • 4. The CE mark must be affixed and labeling has been completed.
  • 5. European Representative.
  • 6. Bio-Vigilance ® system.
    • Solutions in medical devices vigilance after the placing on the market.

BIONOK HEALTHCARE     28042 Madrid

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Phone:+34.911.371.170

info@bionok.eu  

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