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Medical Device Regulatory Consulting
Medical Minds for Market Access
Expert Medical Device Regulatory Consultants
Mantra Systems provides professional UK & EU MDR medical device regulatory consulting services to companies seeking compliance & market access for any class of medical device.
Our unique network of medically-trained consultants will bring unrivalled clinical evidence appraisal & analysis to your medical device regulation strategy.
EnableCE: Your EU MDR Strategy Toolkit
Do it once and do it right with our training courses and fill-in-yourself templates. Gain confidence, reassurance & control over your EU MDR strategy.
Our Clients say
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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.
ABQuality Advisor Manufacturer, UK
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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.
KWChief Executive Officer SaMD Company, UK
Medical Device Regulation Resources
Our Medical Device Regulation Resources contain information and guidance on a wide range of aspects across the regulatory landscape.
For further guidance or any specific enquiries, please contact our specialist consultants.
MDReady Starter Guide A simple, comprehensive and free guide to working with the EU MDR.
Our Clients
We serve an international client-base covering all classes of medical device across a wide range of clinical fields.
Our clients are based around the world, hailing from the UK, Europe, North America, Central America, Asia and the Middle East, and vary in size from pre-market start-ups to stockmarket-listed multinationals.
Our Clients say
Mantra Systems have worked hard to meet our specific needs and have been a pleasure to work with; I would thoroughly recommend them.
TDDr. Trevor Day Principal Scientist Procter & Gamble, UK
Latest articles
Stay informed with our industry-focused publications. You can also follow our updates on LinkedIn & YouTube.
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A medical device's intended purpose - what is the point?
How do you define intended purpose, indication for use, intended clinical benefits, and claims?
Dr Simon Cumiskey
Lead Medical Writer
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EnableChat - Your AI-powered MDR and MDCG chatbot
Search the MDR and MDCG documents in seconds by asking EnableChat your questions.
Dr Simon Cumiskey
Lead Medical Writer
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Staying vigilant - A guide to searching for adverse events data
We discuss the pros and cons of existing adverse event databases for vigilance data searching.
Dr Simon Cumiskey
Lead Medical Writer
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What is Summary of Safety and Clinical Performance (SSCP)?
We explain what the SSCP is, when you'll need it and what its objectives are.
Sandra Gopinath
Senior Regulatory Specialist
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Scientific Validity Reports – Foundation of the IVDR Performance Evaluation
Justifying scientific validity is the first step in proving compliance with the IVDR.
Dr Gayle Buchel
Lead Medical Writer
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Mantra Systems at MEDICA 2023
Mantra Systems is going to MEDICA 2023, the largest medical trade fair in the world. We hope to see you there.
Shen May Khoo
Junior Regulatory Specialist
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Medical Device 'Significant Changes' – Navigating EU MDR Article 120(3) using MDCG 2020-3 rev. 1
Understand what changes to your medical device are considered 'significant' under EU MDR (2017/745).
Shen May Khoo
Junior Regulatory Specialist
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MDR or IVDR - A sibling rivalry?
A guide to easily understanding whether your device is a medical device or an in vitro diagnostic medical device (IVD).
Dr Gayle Buchel
Lead Medical Writer
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What the latest Brexit U-turn means for CE Marking of medical devices in Great Britain
Will Great Britain continue to allow the use of the CE mark for medical devices beyond the 2024 deadline?
Dr Hanna Gul
Lead Medical Writer