CER Writing Services

It takes a team to write a Clinical Evaluation Report (CER). SMD integrates with your team smoothly to help you get your CER written on time, on budget, and within compliance.

Regulations for European medical devices are ever shifting and the new EU Medical Device Regulation (MDR) has much stronger requirements for post-market surveillance (PMS) and post-market clinical follow-up (PMCF). Keeping up with these changes requires experience and knowledge to bring a project to completion. SMD is equipped to benefit your CER project with:

Experienced project managers with wide medical device development experience
Access to physicians, biomedical researchers, and regulatory professionals
Tailored support for large, medium, and small medical device businesses
A focused team-centric customer approach

Keeping a CER up-to-date is a basic requirement for compliance with EU medical device regulations. Failure to do so can result in strong action by regulatory authorities, including loss of CE mark. SMD can help you stay compliant and avoid such actions.

Several options are possible, depending on the situation for your device

New product CER writing
CER Renewal
CER updates from Meddev 2.7.1 Rev 3 to Rev 4, or from MDD to MDR
CER-related procedures
Comprehensive clinical literature search reports
Comprehensive State of The Art literature reports