Medical Device Regulatory Consulting

We make it simpler than it sounds

I need medical device regulatory consultants for EU MDR compliance
I am new to medical device regulation and need to speak with someone
I would like to learn more about EU medical device regulation

We are experts in all areas of the EU MDR

Our team of MDR consultants are medical device regulatory specialists offering tailored MDR compliance services.

Our combined experience allows us to provide a service of the highest professional standard.

We are here to help

Our team of medical professionals have extensive clinical experience in an array of specialities, giving you access to real subject matter experts.

Start by talking with us so we can fully understand your medical device regulatory requirements.

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Start today

Do you need a new regulatory partner?
Are you starting from scratch?
Or do you just need some advice?

Start by talking with us so we can fully understand your requirements.

Your name

Email Phone number

Message

Your privacy is important. See how we handle your data.

We can guide you through the EU MDR

Our range of medical device regulatory resources are free and contain information on all aspects of EU Medical Device Regulation.

For any specific enquiries or further guidance, our team are here to help.

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

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.

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, Medical Device Manufacturer, UK
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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, Medical Device 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.

CEO, Medical Device Company, France
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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.

CEO, Medical Device Software Company, Denmark
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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 Company, UK
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A comprehensive, detailed and highly professional service.

Regulatory Manager, Medical Device Company, 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.