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

    Guidance Resources

Register for our free MDR Compliance Webinar A masterclass on building a winning EU MDR strategy

Register free for our MDR Compliance Webinar

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

Get our free MDReady Starter Guide A complete starter guide to get ready for the EU MDR

Download our free MDReady Starter Guide Guide See all our downloads

Supporting your 
medical device compliance

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

Download our free Mastering the MDR White Paper See all our downloads

MDR Consulting Services

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

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

Download our free PMS in the MDR White Paper See all our downloads

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 free Software as a Medical Device White Paper See whether the EU MDR applies to your application

Download our free Software as a Medical Device White Paper See all our downloads

Latest updates

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

  1. Our online PMCF Checker shows if your medical device requires a PMCF system

    Does my medical device need a PMCF system for MDR compliance?

    Answer 10 quick questions to check whether your medical device requires a PMCF system.
  2. Ensure medical device regulatory compliance of your devices through Brexit

    The impact of Brexit on medical device regulatory compliance

    How to ensure regulatory alignment of your devices in the territories affected by Brexit.
  3. 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.

You can also find our updates on LinkedIn and Twitter

Do you need help with your MDR strategy?

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