Medical Device Regulatory Consultants for EU MDR Compliance

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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.

A comprehensive, detailed and highly professional service.

Regulatory Manager, Manufacturer, UK
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It was a pleasure working with you. We are completely satisfied with your service and look forward to working with you again.

Chief Executive Officer, Software Company, Denmark
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We engaged the services of Mantra Systems to support us with updating our Clinical Evaluation Reports both for MDR (UK) and MDR (EU). From start to finish the engagement and communication has been proactive and timely, keeping us updated throughout the entire process, and the quality of the reports fully met our needs.

Regular meetings were implemented to ensure understanding of both parties and to discuss and address any findings within individual reports. We would engage the CER services again in the future should the need for further support arise.

Head of Clinical Governance & Regulatory Affairs, Manufacturer, UK
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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.

Chief Executive Officer, Manufacturer, France
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Your service surpassed our expectations and added value across our organisation. We feel much better placed to prepare for the MDR.

Chief Executive Officer, Software Company, UK
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All aspects of communication from Mantra Systems have been excellent from initial contact to the conclusion of the projects. There was excellent communication during the projects, included reviews and discussions helping to maintain the momentum and provide the required outcomes.

The work was performed to excellent standards with every part surpassing expectation. The final reports were of an impeccable standard that I am incredibly confident using going forward as part of my technical files.

Regulatory & QA Manager, Manufacturer, UK
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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.