Medical Device Regulatory Consulting Services

We'll get you first-time approval & compliance for your medical devices

Dr Paul Hercock, Chief Executive Officer

  1. Clinical Evaluation Reports for EU & UK market access

    Clinical Evaluation

    With a 100% CER submission success rate under the UK & EU MDR, our team of over 50 medical writers are specialists in handling large projects producing multiple CERs & CEPs in parallel.

    • CERs written for UK & EU MDR compliance
    • All classes of medical device in any clinical field
    • Appropriately qualified CER signatories
    • Unlimited & free assistance with Notified Body review
    • Fully insured ISO & TOPRA-registered provider
    • Updates & reviews to previous CERs & CEPs
  2. Literature Search Protocols & SOTA Reviews for Medical Devices

    Literature Search & Review

    Literature search, review and analysis of medical device clinical evidence conducted by medically-trained subject matter experts and refined for regulatory compliance.

    • Literature search protocols to identify clinical data
    • Clinical evidence appraisal & analysis
    • MedDev 2.7/1 rev 4 & MDCG-compliant service
    • Clinical insight & subject matter comprehension
    • Experienced objectivity & reviewer independence
    • SOTA determination for Clinical Evaluation
    • Direct oversight of project progress
  3. Post-Market Clinical Follow-up PMCF for EU & UK market access

    Post-Market Clinical Follow-up

    Comprehensive design & management of PMCF studies utilising pre-approved clinical investigators to generate high-quality clinical evidence for any class of medical device.

    • GDPR-compliant & ISO certified EDC data collection
    • Study site on-boarding & ethics committee engagement
    • PMCF Plan & other technical document writing
    • Data analysis & generation of PMCF Evaluation Reports
    • Allocated project team & named primary contact
    • Integration with QMS & Risk Management systems
  4. Summary of Safety and Clinical Performance (SSCP) for EU market access

    Summary of Safety and Clinical Performance

    SSCPs from TOPRA-registered medical device regulatory specialists and clinicians who are experts in writing for professional and lay audiences.

    • SSCP writing & readability testing
    • EU MDR & MDCG compliant SSCP service
    • Transparent quotes with fixed pricing & timelines
    • Working with tight deadlines & re-submissions
    • Updates to previous SSCPs & readability reports
    • Ongoing support after SSCP submission

Our Clients say

  • Regular meetings were implemented to ensure understanding of both parties and to discuss and address any findings within individual reports. We would engage the services again in the future should the need for further support arise.


    Head of Clinical Governance & Regulatory Affairs Manufacturer, UK

  • It was a pleasure working with you. We are completely satisfied with your service and look forward to working with you again.


    Chief Executive Officer SaMD Company, Denmark