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.

Are you looking for…

  • Regulatory consulting support?
  • A quote for our services?
  • Help understanding your options?

Whatever you need, contact us today for a free & confidential discussion.

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Our Clients say

  • 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.

    AB

    Quality Advisor Manufacturer, UK

  • Your service surpassed our expectations and added value across our organisation. We feel much better placed to prepare for the MDR.

    KW

    Chief Executive Officer SaMD Company, UK

MDReady Starter Guide A simple, comprehensive and free guide to working with the EU MDR.

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Our Clients

We serve an international client-base covering all classes of medical device across a wide range of clinical fields.

A world map showing the flags of our clients from the UK, Europe, USA, Central America, Asia and the Middle East

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.

Contact us

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.

TD

Dr. 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.

  1. Considering a medical device's intended purpose

    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 Dr Simon Cumiskey Lead Medical Writer
  2. Mantra Systems presents EnableChat, your AI-powered MDR & MDCG chatbot

    EnableChat - Your AI-powered MDR and MDCG chatbot

    Search the MDR and MDCG documents in seconds by asking EnableChat your questions.

    Dr Simon Cumiskey Dr Simon Cumiskey Lead Medical Writer
  3. Searching adverse event databases for vigilance data

    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 Dr Simon Cumiskey Lead Medical Writer
  4. A doctor reading an SSCP document with a patient

    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 Sandra Gopinath Chief Regulatory Officer
  5. A woman in a laboratory looking down a microscope

    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 Dr Gayle Buchel Chief Medical Writer
  6. A pile of question marks

    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 Shen May Khoo Junior Regulatory Specialist
  7. A pile of question marks

    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 Shen May Khoo Junior Regulatory Specialist
  8. A signpost giving unsure directions

    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 Dr Gayle Buchel Chief Medical Writer
  9. An EU and UK flag

    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 Dr Hanna Gul Lead Medical Writer

More articles

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