Build a winning MDR compliance strategy

Online workshop overview

Registration has now closed. Please see our other available events.

  • Pre-course material that provides a solid foundation in the topic and a thorough overview of information to be covered.
  • A live webinar covering the material in detail and building upon that covered in the pre-course.
  • A live Q&A to address any questions or explore any topics in further detail.

Topics

  1. Understand the MDR in detail and become comfortable working with the MDR as a tool.
  2. Eliminate reliance on misleading and inaccurate secondary sources.
  3. Apply your understanding of the MDR to build strategies in Risk Management, PMS, PMCF, Vigilance, Gap Analysis and Clinical Evaluation that will drive MDR compliance of your company.

Details

  • Online workshop: Build a winning MDR compliance strategy
  • Date: 4th August 2020
  • Time: 12 noon
  • Duration: 2 hours
  • Location: Online
  • Delegate fee: £350

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Registration has now closed. Please see our other available 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

    • 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