Systematic Literature Review & Clinical Evaluation
We begin the process of demystifying the process of systematic review of literature for Clinical Evaluation.
Sandra Gopinath
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 consultants are medical device regulatory specialists offering tailored EU 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.
Call us to discuss your MDR requirements:
Or send your details and we will contact you:
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.
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Our Clients
We work with medical device companies based in the UK, Europe, the US and Asia, developing MDR strategies for all classes of physical and software medical devices.
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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
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A comprehensive, detailed and highly professional service.
Regulatory Manager, 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, 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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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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Latest updates
Stay informed with our industry-focused publications. You can also follow our updates on LinkedIn, YouTube & Twitter.
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Sandra Gopinath
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Keeping medical devices in market & maintaining CE-marks
The 4 golden rules to drive regulatory compliance with PMCF and vigilance data collection.
Dr Paul Hercock
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How PMCF goes beyond simple compliance
The wider benefits of a well-designed PMCF system include improving your products and your relationship with your clients.
Dr Paul Hercock