- 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
EnableCE Build Gap Analysis Tool
Quickly evaluate your regulatory strategy against EU MDR requirements for all your medical devices
Step-by-step analysis for complete confidence
- Reusable 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.
-
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.
-
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.
-
Please see the Gap Analysis comparison chart.
-
No - following purchase, it is yours to keep without any additional payments.
-
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.
KWChief Executive Officer SaMD Company, UK
-
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 evaluation checklist immediately after purchase.
Gap Analysis Tool
- Reusable 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
-
For all purchases, you will receive a receipt by email confirming payment.
Templates & tools:
You will receive an email containing a link to download your files.Training courses:
You will go through the account set up process to access the training course platform.Training course + template package:
You will go through the account set up process to access the training course platform. Within one working day you will receive an email to download your template(s).
You may also be interested in…
-
Learn Understanding the EU MDR Training Course
Gain clarity & context on overall EU MDR requirements for your entire regulatory strategy
-
Learn Risk Management Training Course
Learn how to build & maintain your ISO 14971:2019-compliant Risk Management System
-
Build CER Template Guidance Document
Produce Clinical Evaluation Reports for any class of medical device using a proven start-to-finish methodology