Fractional Regulatory Consulting

How it works
  • Our team operate as a direct extension to yours
  • We'll complete your technical files for MDR / IVDR compliance
  • All the benefits of an in-house professional at a lower cost
  • Get just the support you need - on a rolling monthly basis

Everything you need for MDR / IVDR compliance

  • From non-conformities to full technical file production
  • Access our experience across all device types & classes
  • Work with our in-house regulatory experts & medical writers

Tailored to your needs

  • Dedicated collaboration from a named project lead
  • Overcome capacity or knowledge constraints
  • Ongoing support for UKCA & CE-marking
Happy women working

Predictable, transparent pricing

  • A single, all-inclusive monthly fee
  • Lower initial costs & no long-term contract
  • No minimum term - cancel at anytime

Get started today

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Is this right for your medical device?

  1. That's OK. We can provide systematic help, support and organisation for your circumstances. This monthly model is ideal for access to experts to guide you. Just starting is good, but starting in the correct order with an expert-backed plan is better.

  2. That's fine. Just tell us what you have and we can start work in the background while you finalise what you need to.

  3. Of course. We work on everything from re-engineering resubmissions, starting new submissions, through to continued recertification support.

  4. No problem. Tell us what you require and we'll provide an estimated time frame so you only pay for what you need. If you decide you require more support then we can work on tasks in tandem or parallel. The monthly contract can roll for as long as you need expertise or guidance with other aspects of your submission.

  5. We have the experience and capacity to help get your device to market whatever your circumstances. Please contact us to discuss your personal requirements.

What's included in the single monthly fee?

We cover everything you need for your medical device approvals

  1. Medical Device Regulatory Consulting Services

    UK & EU MDR Consulting

    Achieve medical device regulatory approval for UKCA & CE-marking.

    • Technical File Production
    • Clinical Evaluation
    • Systematic Literature Reviews
    • Risk Management
    • Clinical Strategy Development
    • PMS & PMCF
    • Quality Management Systems
    • Further MDR Services
  2. In vitro Diagnostic Device Regulatory Consulting

    IVDR Consulting

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

    • Technical File Production
    • Performance Evaluation Reports
    • Systematic Literature Reviews
    • Risk Management
    • PMS & PMPF
    • Quality Management Systems
    • Further IVDR Services
Start today

Why Mantra Systems?

We are your partner to full approval, solving regulatory challenges through tailored routes to compliance

Medical Device Subject Matter Experts

What you get with Mantra Systems…

  • Experts in UK / EU MDR & IVDR
  • Global experience with all classes of device
  • 100% Notified Body approval rate
  • Personalised consulting to suit your needs
  • Named project leads offer direct sight of progress
  • Monthly payment options with no hidden costs

Are you looking for…

  1. Expert regulatory consultants?
  2. A quote for our services?
  3. Help understanding your options?

Whatever you need, contact us today to speak with our team.

We respect your information — Read what this means