“The significance of compliant Clinical Data as part of your regulatory strategy, is more important now than at any previous time…”
Your CER (Clinical Evaluation Report) is the single most important part of your CE Marking data submission and the area in which you are most likely to have a Notified Body non-conformance raised.
Whether your Medical Device is Class I or IIa or IIb or Class III, Clinical Data including a Clinical Evaluation Report (CER) in accordance with the requirements of MEDDEV 2.7/1 rev 4, is a mandatory requirement......there are NO exceptions!
With our 40+ years of experience of Medical Device compliance, with special focus having been on auditing Clinical Data on behalf of UK Notified Bodies..........
.......we are perfectly placed to give you the assurance you need, that your Clinical Evaluation Data meets the MEDDEV 2.7/1 rev 4 requirements.
Please complete the form below for a call back to discuss how we might help you achieve your objectives...
Someone will respond to you as soon as possible, usually within 24 hours.
MDRS-EU, ALTRINCHAM, Cheshire WA15 7SN, GB