Gap Analysis Tool

Quickly evaluate your regulatory strategy against EU MDR requirements for all your medical devices

Gap Analysis Tool

Single one-off payment £95

Buy now

Step-by-step analysis for complete confidence

  • Evaluation spreadsheet
  • Immediately evaluate your EU MDR strategy against requirements and identify critical gaps
  • Gain insight and clarity when allocating resources to update existing systems
  • Assess your entire regulatory strategy in under an hour using a simple point-by-point analysis
  • Designed to meet Notified Body evaluation processes and suitable for any class of medical device

In more detail

Apply a simple and effective EU MDR Gap Analysis technique suitable for all medical device manufacturers.

  1. It is designed for any member of a medical device company with responsibility for ensuring alignment with EU MDR requirements. It does not require specialist regulatory knowledge.

  2. The tool has seven sections which are as follows;

    1. GSPR Conformity
    2. PMS (Post-Market Surveillance)
    3. PMCF (Post-Market Clinical Follow-up)
    4. Clinical Evaluation
    5. Risk Management
    6. Other regulatory processes
    7. Annex II Technical Documents

  3. Quickly perform an analysis of your regulatory strategy and identify important gaps that need to be addressed for EU MDR conformity.

  4. No - following purchase, it is yours to keep without any additional payments.

  5. The tool is a Microsoft Excel spreadsheet and requires no activation or access codes. You will be able to reuse the template for all your medical devices.

Our Customers say

  • Your service surpassed our expectations and added value across our organisation. We feel much better placed to prepare for the MDR.

    KW

    Chief Executive Officer SaMD Company, UK

  • A comprehensive, detailed and highly professional service.

    BG

    Regulatory Manager Manufacturer, UK

Comparison to free Gap Analysis tools

Our Gap Analysis Tool eliminates uncertainty as you work towards EU MDR compliance.

* Includes the most searched for free options
Feature

* Free Gap Analysis tools

Mantra Systems Gap Analysis Tool

Based around MDR requirements

Foundation of a strategy based on the MDR

Yes Yes

Document guide

Based around Annex II & III technical document requirements

Yes Yes

Structured analysis

Perform a structured analysis of gaps in MDR strategy

Yes Yes

Line-by-line guidance

Enables a granular analysis of requirements for PMS, PMCF, Vigilance, Risk Management, Clinical Evaluation & QMS

No Yes

Priority identification

Facilitates prioritisation & harmonisation of MDR activities across your organisation

No Yes

Document checklist

Ensure complete coverage of all requirements within documents

No Yes

GSPR conformity

Evaluate your GSPR conformity & analyse your clinical evidence

No Yes

Resource allocation

A guide to optimal allocation of resources

No Yes

Download today

You can download and use your checklist template immediately after purchase.

Gap Analysis Tool

  • Evaluation spreadsheet

Quickly evaluate your regulatory strategy against EU MDR requirements for all your medical devices

  • Immediately evaluate your EU MDR strategy against requirements and identify critical gaps
  • Gain insight and clarity when allocating resources to update existing systems
  • Assess your entire regulatory strategy in under an hour using a simple point-by-point analysis
  • Designed to meet Notified Body evaluation processes and suitable for any class of medical device

Single one-off payment £95

Buy now

Prices shown exclude UK/EU VAT

  1. After payment you will get access to our Resources platform where all your purchases are stored.

    Invoices can be found in your Settings > Billing section.

Do you have any questions to ask our team?

Contact us