MDR Gap Analyser

Our MDR Gap Analyser tool will enable you to objectively evaluate your regulatory strategy against MDR requirements


  • Covers all MDR requirements

  • Point-by-point analysis

  • Enables efficient resource allocation

  • A lifetime of free revisions

How it works

Our MDR Gap Analyser is a powerful tool for analysing each component of your regulatory strategy.

  • Get granular analysis of requirements for PMS, PMCF, Vigilance, Risk Management & QMS.

  • Go through the checklist of technical documents, plans, reports & files.

  • Evaluate your GSPR conformity & analyse your clinical evidence.

Comparison to free gap analysis tools*

Eliminate uncertainty while working towards EU MDR compliance through our market-leading Gap Analyser tool.

* Comparison made between our Gap Analyser and gap analysis tools available on the internet.

Free gap analysis tools

Mantra Systems Gap Analyser

Strategy guide Ability to build strategy based on MDR Yes Yes
Document guide List of required technical documents Yes Yes
Structured Structured analysis of gaps in MDR strategy Yes Yes
Document contents Breakdown of contents within technical documents No Yes
Thorough Line-by-line analysis of all MDR requirements No Yes
Resource allocation A guide to optimal allocation of resources No Yes
Live A live resource that can harmonise MDR activities across your organisation No Yes

Buy & Download

Evaluate your MDR strategy today. Our tool is available for immediate download after purchase.

Identifying gaps enables a targeted allocation of resources and helps secure regulatory approval:

  1. Rapid overall assessment of your strategy.
  2. Clear information on deficiencies.
  3. Ensures all aspects of MDR compliance are addressed.

A one time payment of £300 (£360 inc. VAT)

Compatible with Microsoft Excel / 365 Single User Licence / Unlimited copies / XLSX format

After purchase, you will be able to download your licenced copy immediately. You will also receive a confirmation email containing a link to download your copy. Your Single User Licence allows uploading to Microsoft 365.

to discuss:

  • payment through invoice
  • Multi User Licence pricing
  • any other purchase-related queries

Do you need help with your MDR strategy?

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