Since June 2016, when revision 4 of MEDDEV 2.7/1 CLINICAL EVALUATION was issued, Clinical Evaluation Reports (CER) have become more challenging for medical device manufacturers to prepare, update and maintain. The changes in reporting requirements that now feature in MEDDEV 2.7/1 revision 4 and the additional scrutiny that Notified Bodies are applying during their review, highlights the importance of this report in supporting CE marking.
Clinical Evaluation Reports (CER)
We are a team of regulatory professionals and senior medical writers experienced in performing literature searches (PubMed, Embase and vigilance databases) and authoring CERs for both high-risk medical devices and lower class devices. Our staff can come on site for initial onboarding and then complete the CER remotely.
Contact: [email protected] for further details
Company’s Keywords:
cardiovascular, ent, oncology, orthopedics, ophthalmology, urology, cns, diabetes, neurology
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