Medical Device Regulatory Consulting Enabling MDR & IVDR Compliance

Expert Medical Device Regulatory Consultants

Mantra Systems provides a full suite of MDR & IVDR consulting services to companies worldwide seeking access to EU & UK markets for any class of medical device.

Our medically-trained consultants & subject matter experts will bring specialised clinical evidence appraisal & analysis to your medical device regulation strategy.

Our Clients say

Mantra Systems have provided outstanding quality literature search reports and State of the Art appraisals for our medical devices; I would thoroughly recommend them.

TD

Dr. Trevor Day Principal Scientist, UK Procter & Gamble

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Why Mantra Systems?

We'll help you overcome the key steps in medical device approval with complete confidence, ensuring market access for your devices in the UK & EU

Emily Roberts

With Mantra Systems

  • Dedicated experts in all areas of the MDR & IVDR
  • Regulatory services for both EU & UK markets
  • All types & classes of medical device
  • Named project lead to support you throughout
  • Exclusively focused on medical device submissions
  • Guidance with Non-Conformity Reports
  • Fixed timelines + commitment to meet your deadlines
  • Direct & constant visibility of project progress
  • Unlimited post-submission support until full approval
  • No final invoice until you are 100% satisfied

Contact us

With other medical device regulatory consultancies

  • Extra cost for Notified Body responses
  • No communication with project leader
  • Dictative rather than collaborative
  • Undifferentiated 'me too' offering
  • Unclear pricing and timelines
  • Impersonal approach
  • Pharma focused
  • 310+ Satisfied Clients
  • 77% Return Customers
  • 100% Notified Body Approval

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' expertise, attention to detail towards appropriate literature papers, and dedication to accuracy have truly made a difference. Their commitment to delivering high-quality work is evident and I look forward to the possibility of working together again in the future.

    A

    Ambal Engineering Quality & Regulatory Manager, Worldwide LifeSignals

  • Not only was 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. We have worked with other contractors in the past, and we were never satisfied with the output. The work that was completed always required us to put in a lot of extra labor to format and finalize (and sometimes completely redo) what was provided – that is not the case with Mantra Systems. We hope we have another opportunity to work with Mantra Systems again.

    CC

    Courtney Civik Regulatory Affairs Manager, USA Northgate Technologies Inc.

Latest articles

Stay informed with our industry-focused publications. You can also follow our updates on LinkedIn & YouTube.

  1. EU flags

    Regulation (EU) 2024/1860 - Its impact on EU MDR and IVDR

    How does the recent Regulation (EU) 2024/1860 amendment affect the EU MDR & IVDR?

    Shona Richardson Shona Richardson Regulatory Medical Writer
  2. EU flag

    MDCG 2024-10 - Orphan medical devices

    How to apply MDR pre-market clinical evidence requirements to medical devices intended for limited usage.

    Dr Simon Cumiskey Dr Simon Cumiskey Lead Medical Writer
  3. Considering a medical device's intended purpose

    A medical device's intended purpose - what is the point?

    How do you define intended purpose, indication for use, intended clinical benefits, and claims?

    Dr Simon Cumiskey Dr Simon Cumiskey Lead Medical Writer
  4. Mantra Systems presents EnableChat, your AI-powered MDR & MDCG chatbot

    EnableChat - Your AI-powered MDR and MDCG chatbot

    Search the MDR and MDCG documents in seconds by asking EnableChat your questions.

    Dr Simon Cumiskey Dr Simon Cumiskey Lead Medical Writer
  5. Searching adverse event databases for vigilance data

    Staying vigilant - A guide to searching for adverse events data

    We discuss the pros and cons of existing adverse event databases for vigilance data searching.

    Dr Simon Cumiskey Dr Simon Cumiskey Lead Medical Writer
  6. A doctor reading an SSCP document with a patient

    What is Summary of Safety and Clinical Performance (SSCP)?

    We explain what the SSCP is, when you'll need it and what its objectives are.

    Sandra Gopinath Sandra Gopinath Chief Regulatory Officer
  7. A woman in a laboratory looking down a microscope

    Scientific Validity Reports – Foundation of the IVDR Performance Evaluation

    Justifying scientific validity is the first step in proving compliance with the IVDR.

    Dr Gayle Buchel Dr Gayle Buchel Chief Medical Writer
  8. A pile of question marks

    Mantra Systems at MEDICA 2023

    Mantra Systems is going to MEDICA 2023, the largest medical trade fair in the world. We hope to see you there.

    Shen May Khoo Shen May Khoo Junior Regulatory Specialist
  9. A pile of question marks

    Medical Device 'Significant Changes' – Navigating EU MDR Article 120(3) using MDCG 2020-3 rev. 1

    Understand what changes to your medical device are considered 'significant' under EU MDR (2017/745).

    Shen May Khoo Shen May Khoo Junior Regulatory Specialist

More articles

Do you need help with your regulatory strategy?

Contact us today