- 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
MDR Compliance Checker & Gap Analysis Tool
Evaluate your regulatory strategy against EU MDR requirements for all your medical devices
Step-by-step analysis for complete confidence
- Evaluation checklist
- 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 nine sections which are as follows;
1. General requirements
2. GSPR Conformity
3. PMS (Post-Market Surveillance)
4. PMCF (Post-Market Clinical Follow-up)
5. Clinical Evaluation
6. Risk Management
7. Other regulatory processes
8. Annex II Technical Documents
9. Special Cases -
Quickly perform an analysis of your regulatory strategy and identify important gaps that need to be addressed for EU MDR conformity. It will produce a personalised scorecard precisely identifying areas in need of focus.
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Please see the Gap Analysis comparison chart.
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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 Clients say
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We engaged the services of Mantra Systems to support us with updating our CERs for multiple devices both for the EU & UK MDR. From start to finish the engagement and communication has been proactive and timely, keeping us updated throughout the entire process, and the quality of the reports fully met our needs.
Pamela Head of Clinical Governance & Regulatory Affairs
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A comprehensive, detailed and highly professional service.
Kris Regulatory Manager
Comparison to free Gap Analysis tools
Our MDR Compliance Checker eliminates uncertainty as you work towards CE-marking for your medical devices.
* Other |
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 |
Resource allocationA guide to optimal allocation of resources |
No | Yes |
Download today
You can download and use your checklist template immediately after registering.
MDR Compliance Checker & Gap Analysis Tool
- Evaluation checklist
Evaluate your regulatory strategy against EU MDR requirements for all your medical devices
FREE
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