The need: A multinational medical device company required MEDDEV 2.7.1 Rev4 compliant Clinical Evaluation Reports (CER) for several Class IIb and III products in anticipation of a forthcoming audit.
The solution: The Medilink team has been authoring CERs for medical device companies since 2010, using extensive knowledge of guidelines and know-how to produce audit-compliant reports which make the most of the clinical evidence supporting the product.
The Medilink team began by reviewing indications, claims and all published and unpublished evidence supporting each product on the market through targeted searches of multiple clinical databases. This determined the strategy for the CERs. The evidence was categorised according to the hierarchy of clinical evidence and critically analysed against each claim and indication to demonstrate that the benefits of using each product outweighed the risks. Medilink takes care to identify any gaps in evidence which may be problematic so that the client organisation can remediate these in time for an audit. Finally, Medilink also highlights any evidence discovered during searches which might support additional claims and indications and expand the product’s capabilities.
Finally, the Medilink team critically appraised all evidence of product safety and ensured that the state of the art and technical and biological descriptions of each product were robust.
The outcome: The notified body audit was passed and Medilink received excellent feedback on the quality and design of the reports. The reports have been structured in such a way to make it as easy as possible for an auditor to navigate through and find the evidence they are looking for.
If you need to create a CER for your product, contact us on firstname.lastname@example.org to find out how we can help you.
Don't take our word for it...
"Medilink have authored clinical evaluation reports (CERs) for two of our class III implantable surgical sealant devices. From an initial gap analysis to the authorising of our full CERs, the Medilink Professional Partner Service team worked professionally and efficiently with our internal regulatory department. We are delighted with the timeliness and quality of the reports delivered and look forward to working with Medilink in the future."
Peter Maver, Managing Director, Tissuemed Ltd
"BioMin Technologies commissioned Medilink to author a clinical evaluation report (CER) for a class IIB device technical file submission with a tight deadline and were delighted with both the quality and speed of the report. In fact it’s the best overview and review of our product I have seen and we will use it for technical, marketing and other purposes. Many thanks to Medilink a great job."
Richard Whatley, CEO, Biomin Technologies Ltd
“The Medilink team have authored numerous Clinical Evaluation Reports to support a variety of advanced wound healing products ranging from class I to class III medical devices. The reports have always been of extremely high quality, delivered on time and have been received favourably by the notified body”
Regulatory Director, Global Healthcare Company