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Technical Services

Ensuring success by using valid evidence to tell the story

Literature Review

Literature databases are goldmines of information, and Medavise team are experts at finding the hidden nuggets. Understanding a medical treatment state of the art is critical for FDA submissions as well as for EU Clinical Evaluation Reports and Post-Market Surveillance. Medavise uses a standardized overall approach based on the Cochrane Collaboration and the PICO strategy to develop the Research Question. We commonly use the PubMed, EMBASE and Europe PMC databases as well searches of clinical trials registries and other sources of grey literature as needed. Filtering of results is performed using the PRISMA concept. For CERs, the included literature is appraised using a unique method that specifically addresses the MDR and related guidance requirements.


Whether analyzing published data or trying to understanding your own, a good statistician is invaluable. Ours is great.

  • Clinical Investigations – setting minimum sample sizes, writing the Statistical Plan, interim and final data analysis
  • Clinical Evaluation Reports – determining if subject device clinical evidence meets defined safety and performance objectives through meta-analysis
  • Manuscripts – meta-analysis of data supporting systematic reviews

Manuscript Preparation

Having written scores of our own original scientific and medical content – peer-reviewed journal articles, book chapters, conference abstracts, posters and podium presentations – we’ve got the experience to help you effectively communicate your information to the rest of the medical profession.


– 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