ISO 14971:2019 Gap Analysis

ISO 14971 is the international standard for risk management in the medical device industry and is endorsed by regulatory authorities around the world.

It provides a framework for risk management that is applicable to all stages of the device lifecycle, from conception to postmarket surveillance.

And with the rise of complex medical devices and increasing concerns about patient safety, ISO 14971:2019 has become a critical tool for ensuring that medical devices are safe and effective for users.

If you have been complying with the ISO 14971:2007/2012 version and need to ensure you are up-to-date with the latest version of the risk management standard, download this free ISO 14971:2019 Gap Analysis Tool.

This powerful tool is originally priced at $150, but is being offered to you for free by Rook Quality Systems, the developer of the tool and a trusted partner of Greenlight Guru.

This ISO 14971 Gap Analysis Tool will help you:

  • Evaluate your current risk management process. This tool can help you identify areas of strength and areas that need improvement.
  • Identify gaps and deficiencies. This tool can also help you identify any areas where your organization is not fully compliant with ISO 14971:2019.
  • Prioritize areas for improvement. By identifying areas of noncompliance and deficiencies, this tool can help you focus your resources and efforts where they are most needed.
  • Ensure compliance with ISO 14971:2019. By ensuring that your organization is fully compliant with ISO 14971:2019, this tool can help you avoid costly compliance issues and ensure patient safety.

Download your free copy of this ISO 14971:2019 Gap Analysis Tool to ensure compliance with this critical standard and improve your organization's risk management process.

I want this free content!


What's included with this tool:

  • Downloadable excel file that is clear, accessible and easy-to-use
  • Full list of new/updated ISO 14971:2019 clauses with detailed explanations for each
  • Instructions for use of tool
Download Now  

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.