Medical Device CE Marking Consulting & NB Fees

When you need to budget for medical device CE Marking, the following cost should be considered

  1. Cost of testing as per the harmonized standard
  2. Notified Body Fees including auditor travel
  3. Consultants fees towards guidance and preparation of Technical File/Design Dossier
  4. Annual Surveillance Audit
  5. ISO 13485 Implementation and Certification Fees

Please click here to know in detail about the major areas of expences and related pricing.

Important
New documents published by the EU Commission insists for Notified Body direct audit once in 18 months on all clients. This will be an added cost to clients.

 

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