Regulatory
Across all phases of development, we offer three main areas of service:
Support for the compilation and review of your Technical Dossier to MDR.
Compilation of Clinical Evaluation Reports incl. literature searches to MEDDEV 2.7.1./Rev 4 & MDR. Trouble-shooting CER non-conformities.
Expert advice on strategy for borderline classifications.
Clinical Evaluation Report
Every medical device sold into Europe, irrespective of its classification, must have an up-to date Clinical evaluation report (CER) as part of its technical file. Drafting a CER or troubleshooting non-conformities can be a considerable drain on scarce time.
This is where Wound Market Consulting steps in to offload this extra workload by drafting it for you using experts in this field. All CERs for the EU will be drafted against MEDDEV guidelines 2.7.1/rev 4 and under the MDR to ensure the CER is fully compliant.
Our expertise includes:
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Drafting full CERs
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Updating CERs
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Trouble-shooting non-conformities
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Challenge reviews of claims for equivalence
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Consulting on borderline cases
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Clinical literature searches
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Gap-analysis of clinical data
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Reviews of submission dossiers
Ready for the next step?
Let's have a conversation about your goals and challenges, and how Wound Market Consulting can help.