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  • Not only were Mantra Systems very easy to work with, but their clinical knowledge and dedication to helping us meet the tight timelines for response was top notch.

    Courtney Regulatory Affairs Manager Northgate Technologies

  • Their commitment to delivering high-quality literature papers is evident and I look forward to working together again in the future.

    Ambal Engineering Quality & Regulatory Manager LifeSignals

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.

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Our Clients say

  • Mantra Systems have provided outstanding quality SOTAs for our medical devices.

    Trevor Principal Scientist Procter & Gamble

  • Mantra Systems' documentation was approved by our Notified Body on the first review.

    Andrea Compliance Director Cardioline

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Latest articles

  1. A judges gavel sat infront of a Union Jack flag.

    UK Medical Device Regulations Set for Major 2026 Update

    The UK government is preparing to introduce a second major update to the regulatory framework for medical devices, with new pre-market requirements expected to come into effect in 2026.

    Dr Simon Cumiskey Dr Simon Cumiskey Senior Lead Medical Writer
  2. Video poster frame for Episode 3 of our series.

    SOTA Exclusions: The Ongoing Quest for Clarity

    SOTA exclusions aren’t just a box-ticking exercise, they’re a true test of your reasoning and your ability to defend your choices with confidence.

    Kamiya Crabtree Kamiya Crabtree Regulatory Medical Writer
  3. Video poster frame for Episode 3 of our series.

    Clinical Evaluation Masterclass: It is not clear that any systematic search methods were used for the literature review – Episode 3

    Addressing non-conformities isn’t just about avoiding negative outcomes; it’s about building a robust, evidence-based foundation.

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer
  4. A woman writes notes at her desk.

    Regulatory Writing Deadlines: The Pressure to Get It Right the First Time

    Anyone who’s worked in the medical device industry knows that regulatory deadlines aren’t just part of the process—they define it.

    Kamiya Crabtree Kamiya Crabtree Regulatory Medical Writer
  5. Medical phone software being used to communicate with a monitor placed on a mans skin.

    IEC 62366-1:2015 Demystified – Essential Usability Testing for Medical Devices

    What should be included in a Usability Engineering File? What steps do you need to take to ensure compliance and meet standards?

    Kamiya Crabtree Kamiya Crabtree Regulatory Medical Writer
  6. A scientist using a pipette with a microtiter plate and a petri dish.

    Unlocking the Secrets of Effective IVD Device Performance Evaluation

    Whether preparing for a new EU market submission or strengthening existing documentation, this guide is your overview of performance evaluation under IVDR.

    Kamiya Crabtree Kamiya Crabtree Regulatory Medical Writer

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