PharmaLex expertise secures CE certification for medical devices ‘at risk’
- An EU based company manufacture a large portfolio of medical devices for the UK National Health Service. During a recent Notified Body audit, the company’s Technical Files were found to be deficient, and they were issued with a major non conformity against their Clinical Evaluation Reports (CERs).
- With multiple reports requiring update to the new MEDDEV 2.7.1/rev4, there was a real risk of losing their CE certifications and thus, the right to sell their products in the EU. This manufacturer required a consultancy specializing in medical devices, who had clinical writing expertise and strong literature retrieval skills, together with the commitment and can do attitude to meet a very tight deadline.