CER/Technical File Gap Assessment Consultant (224517)
Life Sciences & Technology
| Regulatory Affairs
A BDN client is looking for a CER/Technical File Gap Assessment Consultant who will conduct a Technical File gap assessment for MEDDEV Rev. 4 compliance and EU MDR compliance as well as a Clinical Evaluation Gap Assessment for MEDDEV Rev. 4 and EU MDR compliance for products from the client’s facility. The two products are software devices (Class IIa in EU), and two CERs exist (one for each product), and the technical files are in the Medical Devices site (will establish file/document secured sharing electronically and there will be a point person in Medical Device site for questions and assistance with obtaining documents.) The client assumes the technical files are in decent shape as they have had multi audits (including an MDSAP audit earlier this year), but the CERs were last updated in 2015 (prior to MEDDEV Rev. 4 being implemented), so they are not compliant to Rev 4.