Why you'll almost certainly need a PMCF system for your medical devices
We tell you what to be aware of under the EU MDR regarding PMCF and your medical devices.
Medical Device Regulatory Consulting
We make it simpler than it sounds
How can we help you today?
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.
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.
Register for our free MDR Compliance Webinar A masterclass on building a winning EU MDR strategy
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.
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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, 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.
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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
Articles
Keep up to date with our thoughts on the industry. You can also find our updates on LinkedIn and Twitter.
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Build a winning EU MDR strategy for your medical devices
Watch our CEO, Dr Paul Hercock, deliver a Mantra Systems webinar on MDR compliance strategy.
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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.
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The impact of Brexit on medical device regulatory compliance
How to ensure regulatory alignment of your devices in the territories affected by Brexit.
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Is outside consulting support the answer to your MDR transition?
Getting ready for the MDR is a demanding process. Outsourcing might be your solution.
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Increasing data entry compliance in PMCF studies
5 methods every medical device manufacturer should know to improve their Post-Market Clinical Follow-up studies.