Spiral Medical Development

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.

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

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• 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