How to achieve MDR Compliance for Class I medical devices
We outline a strategy for the regulatory compliance of Class I medical devices.
Sandra Gopinath
Medical Device Regulatory Consulting
We make it simpler than it sounds
How can we help you today?
We are EU MDR experts
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.
Call Monday-Friday 8am-8pm GMT
Your privacy is important. See how we handle your data.
Or send your details and we will contact you:
Your privacy is important. See how we handle your data.
We'll 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 MDReady Starter Guide A complete starter guide to get ready for the EU MDR
Free download - MDReady Starter Guide Guide See all our downloads
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.
-
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
-
A comprehensive, detailed and highly professional service.
Regulatory Manager, Manufacturer, UK
-
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
-
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
-
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
-
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
-
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
Get our Mastering the MDR White Paper A comprehensive summary of the EU MDR
Free download - Mastering the MDR White Paper See all our downloads
Latest articles
Stay informed with our industry-focused publications. You can also follow our updates on LinkedIn, YouTube & Twitter.
-
Sandra Gopinath
-
Systematic Literature Review & Clinical Evaluation
We help to demystify the process of systematic review of literature for Clinical Evaluation.
Sandra Gopinath
-
Literature Reviews for medical devices - what to know before you start
We explain what you should know before beginning a Systematic Literature Review for your medical device.
Sandra Gopinath