5 useful resources when writing a medical device Clinical Evaluation Report (CER)

Writing a Clinical Evaluation Report (CER) is one of the most demanding aspects of preparing a medical device submission under the EU MDR. It calls for a comprehensive appraisal and analysis of all clinical evidence relating to the subject device, along with an objective analysis of data relating to the clinical background and comparable alternative devices.

Because of the breadth of ground each CER needs to cover, they invariably become weighty documents often running to hundreds of pages. As a result, it’s very easy to become lost. It’s therefore vital to know how to structure the document and keep track of all the different sections.

Luckily, there are several resources available to help. Not everything out there is authoritative or reliable, so in this article we outline 5 of the most useful and trustworthy resources to use when writing a medical device CER.

Read the article here:
https://www.mantrasystems.co.uk/artic...

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Be sure to check out our article on how to choose a CER writer for your MDR Clinical Evaluations too:-
https://www.mantrasystems.co.uk/artic...

We recommend visiting our MDR Compliance guide section of the website for FREE content on how to conduct Clinical Evaluation effectively as well as utilising the best procedures for writing Clinical Evaluation Reports.

Clinical Evaluation Guide:
https://www.mantrasystems.co.uk/eu-md...

Clinical Evaluation Report writing:
https://www.mantrasystems.co.uk/eu-md...

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