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

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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

    • Designing your PMS system
    • Vigilance systems
    • Medical complaints
    • Writing PMS plans & PSURs
    • Clinical investigations & product registries
    • Risk management
    • Identify needs for any PACAs / FSCAs
  • 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

    • Design your PMCF strategy
    • Build Medical Device Product Registries
    • Ensure complete lifecycle evidence generation
    • Prepare evidence reports for other departments
    • Reduce time waste on administration
  • 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

    • Performing 360-degree Clinical Evaluations
    • Write & review CERs
    • Systematic literature appraisals
    • Clinical evidence Gap Analyses
    • Clinical development plans
    • Designing & implementing clinical investigations
  • 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

    • Identify your product's general SPRs
    • Find gaps in existing evidence portfolio
    • Systematic literature reviews
    • Clinical development plans
    • Impact analysis on Risk Management processes

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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