Medical Writing

CERES has extensive medical device experiences within Regulatory, Quality and Clinical Affairs. Devices from class III to I, or implants and active implants are subject of our Medical Writing services. We take care of your clinical evaluation report (CER), your CEP, SAP, PMCF, SSCP, PSUR, CIP …

CERES support you in performing, writing, and maintaining your
clincial & regulatory documents efficiently.

Medical writing compliant with the latest regulatory requirements and EU-regulations is a must have for all manufacturers, economic opertors and sponsors.

Services we provide

Clinical Evaluation Report

Do you need a clinical evaluation – either to get the CE-approval for your medical device or to confirm its safety and performance? By means of own clinical data, available data from equivalent devices or a combination of both we create the clinical evaluation report (CER) and accompanying documents addressing your device.

  • Clinical Evaluation Plan (CEP)
  • Clinical Evaluation Report (CER)
  • Demonstrate State Of The Art (SOTA)
  • Literature research
  • Evaluate AE and complaint databases
  • Regular updates

Clincal & Regulatory Writing

In dependence of the risk classification of your device different documents are required.

  • Check General Safety and Performance Requirements (GSPR)
  • PMCF and PMS documentation
       – Post-Market Clinical Follow-up Plan
       – Post-Market Clinical Follow-up Report
       – Post-Market Surveillance Plan
       – Post-Market Surveillance Report
  • Periodic Safety Update Report (PSUR)
  • Summary of Safety and Clinical Performance (SSCP)
  • Clinical trial documents according to ISO 14155, from
       – Synopsis to
       – Clinical investigation report

In addition, we are well networked and can create the entire technical documentation for you with established cooperation partners.

Marketing

According to the MDR “a detailed description of intended clinical benefit with relevant and specified clinical outcome parameters” is required. Manufacturers must take care that all promotional materials are scrutinized for claims of clinical benefit. For printed and online material the company has to decide whether such claims can be confirmed; otherwise these claims for clinical benefit should be removed.

  • Aligned claim sheets
  • Sound Scientific Publications
  • Readable Patient Brochures
  • Medical Marketing

Reporting & Accompanying Services

  • PMS- & PMCF-Report
  • Periodic Safety Update Report
  • Clinical investigation report
  • (S)AE Reporting
  • Standard Operating Procedures,
    templates and forms
  • Localized country-related documents

Your Advantage

Your benefit from our medical writing will be optimized by the cross-functional team. As a full-service CRO – focused on medical devices – we offer medical writing services for both your specific documents and the entire project, including writing and management.


Do you need more information? Feel free to contact us.