Medical Device Regulatory Consulting

We help manufacturers around the world achieve UKCA & CE-marking for their medical devices

  1. Medical Device Regulatory Consulting Services

    UK & EU MDR Consulting

    Achieve medical device regulatory approval for UKCA & CE-marking.
  2. Clinical Evaluation Reports for UK & EU market access

    Clinical Evaluation

    Market-leading CER & CEP writing services to support UK & EU medical device approvals.
  3. In vitro Diagnostic Device Regulatory Consulting

    IVDR Consulting

    Ensure Notified Body acceptance through expert in vitro diagnostic device regulatory consulting.

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 man carefully steps across a cliff-face. An analogy for assessing risk.

    Top 5 Common Pitfalls to Avoid During Risk Assessment

    Learn how to sidestep costly mistakes which manufacturers commonly make. From hazard ID to post-market surveillance, we help you improve safety and speed up approvals.

    Kamiya Crabtree Kamiya Crabtree Regulatory Medical Writer
  2. A label maker printing bar-code labels.

    Labelling 101: A Comprehensive Overview for Medical Device Manufacturers

    Labelling and packaging are critical elements to ensuring safety, compliance, and ease of use.

    Kamiya Crabtree Kamiya Crabtree Regulatory Medical Writer
  3. An illustration of a brain-shaped object on an abstract background.

    European Commission Guidelines on Prohibited Artificial Intelligence Practices

    Summary of the 8 AI practices prohibited by the EU 2024/1689 artificial intelligence (AI) Act.

    Dr Clare Dixon Dr Clare Dixon Regulatory Specialist
  4. A compass being used to navigate across mountainous countryside.

    Navigating Non-Conformities in Technical Documentation

    We explore how to manage non-conformities effectively and implement Corrective and Preventive Actions (CAPAs).

    Kamiya Crabtree Kamiya Crabtree Regulatory Medical Writer
  5. A photograph of a literal maze that we're using as a clever metaphor.

    Mastering the EU MDR: Essential Steps for Compliance-Ready Docs

    If you're uncertain about the readiness of your EU MDR documentation, this article provides an overview of the essential steps to ensure you’re on track.

    Kamiya Crabtree Kamiya Crabtree Regulatory Medical Writer
  6. An illustration showing scientists at work.

    A Guide to Electronic Instructions for Use (eIFU)

    Electronic Instructions for Use (eIFUs) are set to revolutionise how medical device instructions are delivered. We explore what this means for you.

    Dr Will Brambley Dr Will Brambley Lead Medical Writer

More articles

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