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Clinical Evaluation Documents
Post Market Surveillance
Post-Market Clinical

Clinical Evaluation

report

We bring in-depth know-how to efficiently craft a fully-compliant Clinical Evaluation Report (CER)

  • CER scoping & planning 

  • Gap analysis

  • Benefit-risk analysis

  • Demonstration of equivalence and/or similarity with similar devices​​

  • Comprehensive and systematic state-of-the-art review

  • PMCF & PMS documentation

  • Literature review 

  • Ongoing updates and CER maintenance  

  • Integration with risk management processes

Post-Market Clinical Follow-Up 

We conduct effective & methodical (PMCF) activities adhering to latest regulatory standards

  • PMCF strategy and plan

  • Data source identification and collection 

  • Data analysis and interpretation 

  • PMCF Evaluation Report 

  • PMCF study protocols and reports

  • PMCF ongoing monitoring and updates as needed

  • Communicating PMCF findings to stakeholders including regulatory bodies

Post-Market Surveillance 

We provide comprehensive (PMS) activities fully compliant with country-specific regulations

  • PMS strategy & execution - requirements from EU MDR, IVDR, ISO 13485-2016, 21 CFR, and guidance documents 

  • PMS plan & procedures

  • PMS data compliance evaluation

  • PMS report and Periodic Safety Update Report (PSUR) compilation and review

  • PMCF requirements from PMS data

  • Post-marketing literature surveillance

Clinical Publications
Clinical Trial Services
Literature Reviews 

Literature Review

We guide your clinical development with comprehensive research reports

  • Research strategy, plan & scope

  • Literature search, selection, data extraction & analysis 

  • Clinical writing & updates

  • Systematic and narrative literature reviews

  • New applications investigation

  • New protocols investigation

  • Medical guidelines review

  • Scientific literature background for your new product or future research

  • Data collection for regulatory purposes & CER submission

Clinical Publications

We craft high-quality clinical materials with effective messaging to amplify your impact in the scientific community

  • Content writing and proofreading

  • Data analysis & visual representation

  • Journal identification, submission & peer review feedback

  • Research articles

  • Opinion pieces

  • Narrative reviews

  • Systematic reviews and meta-analysis

  • Case reports and series

  • Conference presentations & abstracts

Medical Education Materials

We develop comprehensive medical education materials that effectively convey your messaging to inform decisions with diverse target audiences.

  • Content writing and proofreading

  • Educational and training slide decks

  • Scientific abstracts and posters

  • Physician brochures and flyers

  • Scientific & congress slide decks

  • Symposia speaker decks

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