Personalised support

Our personalised support offers the opportunity for you to embed one of our expert medical professionals into your company to provide tailored and personalised training to your regulatory team.

Our personalised support service will enable your specific MDR training needs to be addressed and will avoid the expense of working with external contractors to deliver MDR compliance services.

Limited by availability, we offer the opportunity to receive on-site training from medical professionals who are experts in applying their clinical knowledge to your MDR compliance needs.

Please contact us to discuss your requirements with our team:

Alternatively, send us your details and we will call you back to discuss how our personalised support can help you.

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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