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. US and EU flags on poles alongside each other.

    Clinical Evidence under EU MDR: Leveraging FDA Clinical Data to Streamline EU MDR Compliance

    FDA approval alone is not sufficient for European market access - a theme we explore futher in this article and the accompanying webinar.

    Chandini Valiya Kizhakkeveetil Chandini Valiya Kizhakkeveetil Regulatory Medical Writer
  2. An AI-generated image of 3 people in an office in front of a whiteboard with the words 'Medical Device Market Entry Strategy' written above a world map.

    EU MDR & NHS DTAC Cybersecurity Requirements for UK Market Entry

    This guest article from our partner Cyber Alchemy shows you how to build cybersecurity evidence for the EU MDR and NHS DTAC.

    Luke Hill Luke Hill Co-Founder of Cyber Alchemy
  3. An illustration showing a GPS-driven navigation route superimposed upon someone using a laptop.

    Where to Launch First? A MedTech Founder's Regulatory Roadmap to the EU, UK and US

    Cyber Alchemy × Mantra Systems — Episode 1: All three markets operate under different regulatory systems and place different demands on manufacturers.

    Ronghe Xu Ronghe Xu Regulatory Medical Writer & Strategic BD Lead China
  4. A woman uses an inhaler.

    Navigating EU MDR Article 117: A Practical Guide to Drug-Device Combination Product Submissions

    Implementation of the EU MDR 2017/745 has brought significant changes.

    Chandini Valiya Kizhakkeveetil Chandini Valiya Kizhakkeveetil Regulatory Medical Writer
  5. NHS CEP logo.

    Mantra Systems becomes an official Programme Partner of the NHS Clinical Entrepreneur Programme

    We're proud to join a this initiative supporting healthcare workers and patients to develop innovative solutions for the NHS.

    Paul Hercock Paul Hercock Chief Executive Officer
  6. Collage art showing a pair of binoculars, an analogy for surveillance.

    How EU MDR Post Market Surveillance differs from FDA post-market expectations

    We compare manufacturer-specific post-market obligations across both regulatory systems.

    Dr Gayle Buchel Dr Gayle Buchel Chief Medical Writer

More articles

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