Taking the complexity out of medical device compliance

Learn how or explore our consulting services…
  1. Medical Device Regulatory Consulting Services

    UK & EU MDR Consulting

    Tailored support to secure UKCA or CE-marking for your medical devices.
  2. Clinical Evaluation Reports for UK & EU market access

    Clinical Evaluation

    CEP & CER writing services with success across 250+ submissions spanning all risk classes.
  3. In vitro Diagnostic Device Regulatory Consulting

    IVDR Consulting

    Ensure your in vitro diagnostic medical devices gain first-time IVDR approval.

Our Clients say

  • 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.

Contact us for a same-day quotation

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

Resources for Medical Device Regulation

Get guidance on medical device regulation through exclusive resources written by our subject matter experts

Free MDR Compliance Checker Evaluate your regulatory strategy against EU MDR requirements for all your medical devices

Explore — MDR Compliance Checker & Gap Analysis Tool

Latest articles

  1. A magnifying glass inspecting a number of wooden cubes with question marks upon them laid upon a blue table. The wooden cube under the magnifying glass has a lightbulb painted on it.

    Fixing the MDR and IVDR? The Commission’s Proposed Amendments and What They Mean for Manufacturers

    Exploring the key elements of this proposal.

    Chandini Valiya Kizhakkeveetil Chandini Valiya Kizhakkeveetil Regulatory Medical Writer
  2. An illustration showing a business woman pole-vaulting across a ravine.

    Eliminating the Top 5 Notified Body Gaps in Clinical Evaluation Through Pre-Submission Review

    From insufficient clinical evidence to Post-Market issues - we guide you past common NB deficiencies.

    Chandini Valiya Kizhakkeveetil Chandini Valiya Kizhakkeveetil Regulatory Medical Writer
  3. Two arms point at a sign and hold a question mark, in an abstract pop-art style.

    Regulatory Reset? The EU’s Proposed Changes to MDR and IVDR Explained

    Changes published in December 2025 aim to streamline EU medical device and in vitro diagnostics. We explain who is impacted and how.

    Dr Gayle Buchel Dr Gayle Buchel Chief Medical Writer
  4. A pair of glasses rests on an eye test chart.

    Did You Know Your Glasses Were a Medical Device? A Regulatory Guide for Manufacturers

    The importance of correct classification and our recommended path to avoid common ophthalmic device 'gotchas'.

    Gabriela Cardoso Gabriela Cardoso Regulatory Medical Writer
  5. A man sitting whilst a nurse prepares his arm for an injection.

    Why Clinical Trial Design Should Begin at the Earliest Stages of Medical Device Development

    In this guest post from our partners at Franklyn Health, they explore the benefits of a well-planned approach.

    Rob Bedford Rob Bedford Head of Clinical Operations at Franklyn Health
  6. A precariously balanced pile of ping-pong balls and wooden bars.

    The Shift from MDD to MDR: Key Differences in Demonstrating Equivalence

    This transition has demanded that device safety must be demonstrated with more evidence. We offer tips for winning equivalence claims.

    Kamiya Crabtree Kamiya Crabtree Regulatory Medical Writer

More articles

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