Your MDR compliance Our medical expertise

  1. Our unique MDR consulting services bring real subject matter experts to your regulatory strategy

    Medical Device Regulatory Consulting Services

  2. Benefit from the knowledge of our expertly-trained medical professionals and get ready for the MDR

    Training Academy

  3. Our extensive library of free resources will guide you through the challenges of MDR compliance

    Guidance Resources

Get our free White Paper: Mastering the MDR — A comprehensive summary of the EU MDR

Download our free Mastering the MDR White Paper

Our clients

We work with medical device companies across the industry ranging from pre-start businesses to stockmarket-listed multinationals. We also have strategic partners throughout Europe.

  • I really appreciated your job on our medical device CER. It was truly amazing how you managed to get all this done in such a short notice. I'm very pleased with your work.

    CEO, Medical device company, France

  • It was a pleasure working with you. We are completely satisfied with your service and look forward to working with you again.

    CEO, Medical device software company, Denmark

  • Your service surpassed our expectations and added value across our organisation. We now feel much better placed to prepare for the MDR.

    CEO, MedTech pre-start, UK

  • A comprehensive, detailed and highly professional service.

    Regulatory Manager, Medical device company, UK

  • International

    We work with medical device manufacturers based in the UK, Europe, the US and Asia, developing MDR strategies for both physical devices and software as a medical device.

  • Diversified

    Working with us gives you access to our growing international team of MDR-trained healthcare professionals from a wide variety of clinical backgrounds.

Read more about our team and philosophy

Supporting your 
medical device compliance

MDR Consulting Services

Our team of MDR-trained healthcare professionals are specialists offering tailored Medical Device Regulatory Consulting Services.

Get our free White Paper: PMS in the MDR — A complete summary on medical device Post-Market Surveillance

Download our free PMS in the MDR White Paper

Upcoming events

Our MDR Training Academy runs events designed to quickly and effectively fill gaps in your MDR knowledge-base.

  1. Online workshop MDR Compliance for CEOs/CFOs

    5th May 2021 @ 12 noon GMT

    A workshop designed for senior company decision makers to help them understand MDR compliance strategy and what it means for their company.

  2. Online workshop Software as a Medical Device

    12th May 2021 @ 12 noon GMT

    Learn how to apply the MDR to Software as a Medical Device to ensure regulatory approval and protect your market position.

  3. Online workshop Clinical evidence in the MDR

    19th May 2021 @ 12 noon GMT

    Learn how to use clinical evidence in MDR Gap Analysis, PMS, PMCF & Clinical Evaluation and apply this to your MDR compliance strategy.

  4. Online workshop MDR Compliance for Class I devices

    26th May 2021 @ 12 noon GMT

    Understand the specific MDR compliance requirements for Class I medical devices and how they differ from those under MDD.

MDR Guidance Resources

Our unique MDR Guidance Resources are written by our medical experts and cover all aspects of the new Medical Device Regulation.

Get our White Paper: Software as a Medical Device — See whether the EU MDR applies to your application

Download our free Software as a Medical Device White Paper

Latest updates

Keep up to date with our thoughts on the industry. All our articles

  1. Use medical device regulatory consulting services to supercharge your MDR transition

    Is outside consulting support the answer to your MDR transition?

    Getting ready for the MDR is a demanding process. Outsourcing might be your solution.
  2. Increasing data entry compliance in PMCF studies

    Increasing data entry compliance in PMCF studies

    5 methods every medical device manufacturer should know to improve their Post-Market Clinical Follow-up studies.
  3. Simplifying the challenges posed by the new EU MDR

    Simplifying the challenges posed by the new EU MDR

    Our CEO Dr Paul Hercock was invited to speak on a Kaizen Life Sciences podcast about the challenges posed by the EU MDR.

You can also find our updates on LinkedIn and Twitter

Do you need help with your MDR strategy?

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