Software as a medical device — a guide to MDR compliance

Online workshop overview

  • 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 medical device legislation as it applies to software.
  2. Learn how to apply the MDR to software as a medical device.
  3. Understand how software features will impact product risk classification and requirements for conformity assessment.
  4. Build an MDR compliance strategy to ensure regulatory approval of your software product and protect your market position.

Details

  • Online workshop: Software as a medical device — a guide to MDR compliance
  • Date: 5th August 2020
  • Time: 12 noon
  • Duration: 2 hours
  • Location: Online
  • Delegate fee: £350

Register your place

After registration, we will send you a confirmation email with further instructions.

This is not a committment to buy. We will contact you in due course to confirm your place. If you subscribe to our newsletter, we will send you periodic email updates. You can unsubscribe at any time. Your privacy is important. See how we handle your data.

Stay informed

Subscribe to our newsletter and get free access to our MDR downloads.

You will be subscribed to our email newsletter and be given access to our downloads. You can unsubscribe at any time. Your privacy is important. See how we handle your data.

Any questions?

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

Request callback

Download our free Software as a medical device White Paper

Download

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