Taking the complexity out of medical device compliance

Learn how or explore our consulting services…

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

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 person studying at a desk with pad and paper.

    In the World of Regulatory Writing: 5 Lessons Learned

    Let’s break down some key lessons learned from the writing process and share practical tips to navigate them with clarity (and your sanity) intact.

    Kamiya Crabtree Kamiya Crabtree Regulatory Medical Writer
  2. Poster frame for video with Sue Kemp.

    Do you have the clinical evidence you need to support regulatory approval?

    Sue Kemp makes the case for implementing clinical strategy from day one.

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer
  3. An actual conventional UK passport.

    A New Era for NHS Innovation: ‘Innovator Passports’

    A digital fast-track system aims to transform how new medical technologies are adopted across the NHS, cutting red tape and accelerating access to medtech.

    Kamiya Crabtree Kamiya Crabtree Regulatory Medical Writer
  4. A lab worker uses a pipette to fill samples.

    Finding My Passion at the Intersection of Science, Regulation, and Medical Devices

    Our Regulatory Project Lead, Shen, shares her journey from the lab bench at NIBSC to supporting medical device manufacturers at Mantra Systems.

    Shen May Khoo Shen May Khoo Regulatory Project Lead
  5. LinkedIn live webinar poster.

    From Idea to Approval: Get MDR Ready With Our LinkedIn Live

    An upcoming LinkedIn Live session with Dr. Zhong Wei Khor tailored specifically for healthtech founders.

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer
  6. A man crosses a high-wire across a forest.

    The Never-Ending Document Updates: Navigating Changing Regulations

    Just because you’ve submitted a document, it doesn’t mean the work is done. Clinical Evaluation Reports, Risk Management Files or PMS plans will all need updating.

    Kamiya Crabtree Kamiya Crabtree Regulatory Medical Writer

More articles

Free AI-powered Regulatory Chatbot Ask our chatbot a question about the MDR & MDCG Guidelines. No sign-up — it's free

Ask a question

Are you looking for…

  • Expert Regulatory Consulting?
  • A quote for our services?
  • Help understanding your options?

Whatever you need, contact us today for a same-day quotation.

We respect your information — Read what this means