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It’s all about the evidence

Clinical Investigations | Post-market Clinical Follow-up (PMCF)

The Medavise clinical team was created to support the growing need for clinical study evidence, especially for the European market, and has decades of experience in all facets of clinical investigations. Medavise clinical study experts can either assist your team or carry the entire load on studies conforming to ICH E6 (R2) and ISO 14155:2020.

• Study design and protocol development
• Study plans and forms, including EDC selection and interface
• Study execution, including site selection and training, ethics committee approvals and monitoring
• Statistical planning and analysis
• Report preparation

Clinical Evaluation Report

We know how Notified Body reviewers think. Medavise prepares your CER using a standardized approach of our own design to write the complete, evidence-based story on your unique device. Our experienced clinical and engineering professionals having extensive backgrounds in technology assessment, device design, risk management, complaint investigation, literature reviews, technical writing and the ever-changing regulatory requirements.
CER evaluators need to be suitably qualified. The Medavise group has a background with every class of mechanical, electromechanical, chemical and polymer devices in nearly every part of the body. As subject-matter experts, team members have not only performed scientific and medical research but have prepared and presented original work for medical device patents, scientific posters, book chapters and podium presentations at scientific and medical conferences.

Post-market Surveillance (PMS)

Having up-to-date evidence of device safety and performance is mandatory for every medical device manufacturer. We can help to both develop and implement your PMS Plan.

User Surveys

Surveys aren’t just for the marketing group anymore. While they can’t replace a clinical investigation, they are increasingly useful to support Class I devices and devices considered “well established technologies” in Europe and can be a key PMS activity. Medavise has extensive experience in preparing Survey Plans, Questionnaires and Reports to quantify as much as possible the subjective user experience.


– Clinical investigation
– Post-market surveillance
– User survey
– Clinical Evaluation Report (CER)


– Regulatory strategy
– Ongoing support
– Labeling
– 510(k), PMA, EU, ROW submissions

Quality & Engineering

– eQMS
– Ongoing support
– Design History File (DHF)
– Internal & vendor system audits

technical services

– Biostatistics
– Literature review
– Manuscript preparation