Medical Device Regulatory Consulting

Medical Minds for Market Access

Expert Medical Device Regulatory Consultants

Mantra Systems provides professional UK & EU MDR medical device regulatory consulting services to companies seeking compliance & market access for any class of medical device.

Our unique network of medically-trained consultants will bring unrivalled clinical evidence appraisal & analysis to your medical device regulation strategy.

Are you looking for…

  • Regulatory consulting support?
  • A quote for our services?
  • Help understanding your options?

Whatever you need, contact us today for a free & confidential discussion.

EnableCE: Your EU MDR Strategy Toolkit

Do it once and do it right with our training courses and fill-in-yourself templates. Gain confidence, reassurance & control over your EU MDR strategy.

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Our Clients say

  • Please thank all of your team for their brilliant efforts. Your standard of service, response time, and rigour were outstanding and I would strongly recommend you to any other potential client.


    Quality Advisor Manufacturer, UK

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


    Chief Executive Officer SaMD Company, UK

Medical Device Regulation Resources

MDReady Starter Guide A simple, comprehensive and free guide to working with the EU MDR.

Free download — MDReady Starter Guide Free Download

Our Clients

We serve an international client-base covering all classes of medical device across a wide range of clinical fields.

A world map showing the flags of our clients from the UK, Europe, USA, Central America, Asia and the Middle East

Our clients are based around the world, hailing from the UK, Europe, North America, Central America, Asia and the Middle East, and vary in size from pre-market start-ups to stockmarket-listed multinationals.

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Our Clients say

Mantra Systems have worked hard to meet our specific needs and have been a pleasure to work with; I would thoroughly recommend them.


Dr. Trevor Day Principal Scientist Procter & Gamble, UK

Do you need help with your regulatory strategy?

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