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.

Get free access to our MDR downloads including updates of our latest news and events.

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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

Do you have any questions about our services or training?

Contact us