- 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
Gap Analysis Tool
Quickly evaluate your regulatory strategy against EU MDR requirements for all your medical devices
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.
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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.
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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 -
Quickly perform an analysis of your regulatory strategy and identify important gaps that need to be addressed for EU MDR conformity.
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Please see the Gap Analysis comparison chart.
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No - following purchase, it is yours to keep without any additional payments.
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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
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Your service surpassed our expectations and added value across our organisation. We feel much better placed to prepare for the MDR.
KWChief Executive Officer SaMD Company, UK
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A comprehensive, detailed and highly professional service.
BGRegulatory Manager Manufacturer, UK
Comparison to free Gap Analysis tools
Our Gap Analysis Tool eliminates uncertainty as you work towards EU MDR compliance.
* Free |
Mantra Systems Gap Analysis Tool |
|
|---|---|---|
Based around MDR requirementsFoundation of a strategy based on the MDR |
Yes | Yes |
Document guideBased around Annex II & III technical document requirements |
Yes | Yes |
Structured analysisPerform a structured analysis of gaps in MDR strategy |
Yes | Yes |
Line-by-line guidanceEnables a granular analysis of requirements for PMS, PMCF, Vigilance, Risk Management, Clinical Evaluation & QMS |
No | Yes |
Priority identificationFacilitates prioritisation & harmonisation of MDR activities across your organisation |
No | Yes |
Document checklistEnsure complete coverage of all requirements within documents |
No | Yes |
GSPR conformityEvaluate your GSPR conformity & analyse your clinical evidence |
No | Yes |
Resource allocationA 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
Single one-off payment £95
Prices shown exclude UK/EU VAT
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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.
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