Live seminars

Our live seminars run periodically throughout the year and deliver live, expert training in all aspects of the MDR and its application to regulatory approval of your medical devices.

Seminars are tailored to specific groups and sets of medical device, ensuring that seminar content is maximally relevant to your requirements.

Due to the current coronavirus pandemic, our live seminars are set with provisional dates. Registration is open, but we are guided by advice from the UK Government. When restrictions are lifted enough for us to run them safely, we will email each delegate and ask them to confirm their place.

Available seminars

  1. Clinical evidence in the MDR

    • Develop a new level of confidence in applying clinical evidence to your MDR compliance strategy.
    • Understand how to use clinical evidence in MDR Gap Analysis, PMS, PMCF and Clinical Evaluation.
    • Understand aspects of clinical evidence interpretation that you always felt were beyond your grasp and feel confident in handling all types of clinical data.
    • Develop a deep understanding of study power, study types, significance levels and other technical elements that will boost your competence in working with clinical evidence.
    • Date: 9th September 2020
    • Delegate fee: £650 (includes lunch & refreshments)

    More information about the Clinical evidence in the MDR online workshop

  2. MDR Compliance for Class I devices

    • Understand the specific requirements for MDR compliance of Class I medical devices.
    • Understand how requirements differ from those under MDD.
    • Learn what to do to prepare your regulatory strategy for full implementation of the MDR.
    • Date: 16th September 2020
    • Delegate fee: £650 (includes lunch & refreshments)

    More information about the MDR Compliance for Class I devices online workshop

  3. MDR Compliance for CEOs/CFOs

    • A seminar specifically geared towards senior company decision makers who require an overview of the MDR and what it means for their company.
    • Delivered by a fellow company founder, this seminar focuses on business-critical aspects of MDR compliance that will ensure you maintain regulatory approval of your products after May 2021.
    • Date: 23rd September 2020
    • Delegate fee: £650 (includes lunch & refreshments)

    More information about the MDR Compliance for CEOs/CFOs online workshop

  4. Clinical evaluation for Class III devices — do you have what it takes?

    • An in-depth exploration of preparing towards and conducting clinical evaluation of Class III medical devices.
    • Understand the impact of this risk classification on designing and implementing clinical evaluation activities.
    • Date: 30th September 2020
    • Delegate fee: £650 (includes lunch & refreshments)

    More information about the Clinical evaluation for Class III devices — do you have what it takes? online workshop

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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