Gap Analysis Bridging the gap between companies and compliance

Comprehensive Gap Analysis forms the basis of effective MDR transition and resource allocation.

Objective Gap Analysis for clear decision making

A Gap Analysis is a crucial first step in developing an MDR transition strategy, enabling optimal allocation of resources and targeted evidence generation.

By applying our clinical knowledge and MDR expertise, we will produce structured guidance enabling you to address any regulatory compliance gaps well ahead of full MDR implementation.

  • Gap Analysis by medical experts

    We apply our clinical expertise to identify critical gaps in your regulatory and clinical evidence portfolio.

  • Preparation for MDR transition

    Allocate resources where they are needed most while saving costs and avoiding unnecessary task duplication.

  • Funding support

    Our service provides evidence for spending decisions, improving corporate governance and investor relations.

Our Gap Analysis process

Mantra Systems' Gap Analysis process

Our Gap Analysis service begins with a free consultation to discuss your requirements.

Our specialists will then perform a systematic examination of your regulatory structures and clinical evidence portfolio before summarising recommendations in a detailed report.

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Start your MDR transition journey

Performing a detailed Gap Analysis ensures that you focus on addressing only those areas that would otherwise hinder compliance with the MDR.

We believe that MDR Gap Analysis requires a combination of clinical expertise and a deep knowledge of the MDR, available to you through our medical experts.

  • Robust & auditable processes

    We directly reference MDR standards, ensuring complete compliance of reported outcomes.

  • Ongoing support

    Full package of consulting services to enable MDR compliance whilst minimising costs.

Call us now to discuss your MDR requirements:

(+44) 0114 386 3349

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MDR Consulting

Our team of medical doctors are specialists at building the clinical evidence portfolio that you need for MDR compliance of your products.

Use our MDR Requirements Matcher to see which GSPRs apply to your products

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MDR Training

Our comprehensive training services are delivered by experts and address all aspects of MDR compliance.

MDR Guidance

Our unique MDR guidance resources are written by our medical experts and free to use. They cover all aspects of the new Medical Device Regulation.

Do you have any questions about our MDR services?

Contact us