Knowledge base

Our knowledge base contains useful information on all aspects of MDR compliance.

Our articles, which are regularly updated by our team, sit alongside the EU MDR Compliance Guide written by our medical experts to cover all aspects of the new Medical Device Regulation.

We also have a range of White Papers, documents and MDR tools which are free to download.

Downloads

  • Mastering the MDR — This White Paper summarises the MDR and makes its contents easy to digest. It is intended to highlight those areas in the text that are most relevant to medical device manufacturers.
  • PMS in the MDR — The MDR places a higher burden on manufacturers in many areas including PMS system design, implementation and reporting. This White Paper offers guidance on the requirements for PMS in the MDR.
  • Software as a medical device — Understand when and why the MDR applies to medical software, a rapidly growing sector of the medical device market. Learn whether or not the MDR will apply to your software product and how to work with the new legislation.
  • MDR Requirements Matcher — This tool will instantly navigate Annex I MDR, quickly showing you which General SPRs apply to your products without the need to manually search.

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If you have any questions about our MDR training, please get in touch.

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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

Do you have any questions about our services or training?

Contact us