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Are you thinking of marketing your medical device in Europe?

If so, you must write a clinical evaluation report (CER) as part of your Technical File submission for CE marking. The CER is a key document of the CE Marking process, so it is important to get it right. The EU Directive stresses the importance of the CER and includes specific requirements.
It also requires you to provide your CER even after you receive your CE Marking certificate.

AML Christensen works closely with you and delivers cost effective Medical Device Clinical Evaluation Report (CER) for CE Marking to the high standards.

Are you thinking of planning a clinical trial?

If so, AML Christensen can assist you with planning pre- and post-market clinical trials for medical devices.

We can assist you with:

  • Application for the Ethical Committee
  • Study protocols
  • Brochures for investigators
  • Brochures for patients

Growing medical device manufacturers have a lot of challenges, and money is often tight. That is why AML Christensen charges a fixed flat fee for the services. You will know exactly how much it will cost to achieve a specific goal. 

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