General Safety and Performance Requirements (GSPR) Gap Assessment

Demonstrating conformity to the General Safety and Performance Requirements (GSPR) is the cornerstone of establishing compliance with the EU MDR, since the GSPRs are considered universally applicable to all medical devices.

The best way medical device manufacturers can avoid nonconformity is to perform a gap assessment and track which data is required, which you can do by using this free GSPR Gap Assessment Tool, which is normally sold for $150.

This powerful tool, developed by Rook Quality Systems, allows medical device companies to directly compare the old Essential Requirements (ER) of the Medical Device Directives (MDD) to the new GSPRs of EU MDR.

What's included with this tool:

  • Safety and Performance Requirements SOP covering full list of requirements from all 3 chapters of GSPR (valued at $150)
  • Instructions for Use document with steps to walk you through how to use the tool

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This tool will help you:

  • Determine which GSPRs are relevant to your device
  • Identify what data is required for demonstrating conformity with the relevant GSPRs
  • Organize the additional data required to transition from the ERs to GSPRs 
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About Rook Quality Systems

Rook Quality Systems is a consulting firm dedicated to helping medical device companies develop and maintain effective and efficient quality systems. For over a decade, Rook has specialized in Quality and Regulatory strategies for its medical device clientele. 

At Rook, our mission is to enable clients to implement compliant Quality Management Systems (QMS) so that they can efficiently produce effective and reliable medical devices. We build these QMS so that our clients can get their devices to market faster than standard methods, and once on the market, manage these systems to continue producing quality devices. 

Rook provides clients with all of the right resources and necessary tools to comply with regulations in domestic and international markets. Rook's team provides expertise in FDA regulations, MDSAP audits, ISO 13485:2016 compliance, and MDR conformity. We work with a wide range of devices (including class I-III devices, SaMD, and IVDs).

Visit their website to learn more.


About Greenlight Guru

Greenlight Guru is the leading cloud-based platform purpose-built for MedTech companies.

The end-to-end solution goes beyond traditional QMS needs by integrating cross-functional teams, processes, and data throughout the entire product lifecycle so device makers can proactively overcome execution gaps, streamline compliance, and accelerate market success.

Greenlight Guru’s platform is used by organizations across the globe that are replacing their disjointed, legacy tools and solutions to bring life-changing products to people faster, and with less risk.

Visit our homepage to learn more.