Your MDR compliance. Our medical expertise.

  1. Imagine having access to expertly-trained medical doctors and applying their clinical knowledge to your MDR compliance strategy.

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  2. Build your compliance strategy with our modular MDR services to ensure ongoing regulatory approval of your medical devices.

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  3. Learn about the new MDR and become an expert through our White Papers, workshops, seminars, personalised support and knowledge base.

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Download our free Mastering the MDR White Paper — Our easily digestible summary of the EU MDR

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MDR Services

Our team of medical doctors are specialists at building the clinical evidence portfolio that you need for MDR compliance of your products.

  • Through our bespoke Post-Market Surveillance (PMS) service we will apply clinical knowledge to design, update, implement, and maintain your MDR compliant PMS systems.

    Learn more about our Post-Market Surveillance service

    • PMS system design
    • Vigilance systems
    • Complaints handling
    • PMS plan & PSUR writing
    • Clinical investigations
    • Risk management
    • PACA / FSCA need identification
  • Our medical experts will design a robust and adaptable clinical evidence generation system to collect Post-Market Clinical Follow-up (PMCF) data on your medical devices.

    Learn more about our Post-Market Clinical Follow-up service

    • PMCF strategy design
    • Build Medical Device Registries
    • Complete lifecycle evidence generation
    • Evidence reports for other departments
    • Reduce administration time
  • Our full Clinical Evaluation service involves a 360-degree analysis of your medical devices, writing and reviewing CERs, and designing clinical development plans.

    Learn more about our Clinical Evaluation service

    • 360-degree Clinical Evaluations
    • CER writing / reviewing
    • Literature appraisals
    • Clinical evidence Gap Analysis
    • Clinical development plans
    • Clinical investigation design / implementation
  • Our medics will apply powerful clinical techniques to quickly and effectively identify and minimise any gaps in your clinical evidence portfolio.

    Learn more about our Gap Analysis service

    • Genreal SPR identification
    • Evidence portfolio gap analysis
    • Literature reviews
    • Clinical development plans
    • Risk Management impact analysis

MDR Training

Our comprehensive training solutions are delivered by experts and address all aspects of MDR compliance.

Use our MDR Requirements Matcher to see which General SPRs apply to your products

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Do you have any questions about our services or training?

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