Cybersecurity Gap Assessment Checklist

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Cybersecurity Gap Assessment Checklist

In the ever-evolving field of medical devices, staying ahead of cybersecurity regulations is crucial. FDA's recent guidance documents, with a focus on cybersecurity in medical devices, marks a pivotal shift.

The standout document, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submission (Draft Guidance), is set to redefine the standards, replacing the existing guidance on cybersecurity management in medical devices once finalized.

For medical device manufacturers, integrating these cybersecurity considerations into the device development lifecycle is a complex and critical task. This challenge is further intensified by the need to comply with the rigorous processes outlined in IEC 62304:2006/Amd:2015.

We are excited to present a new Cybersecurity Gap Assessment Checklist to assist you along the way, which is being offered to you for free by Rook Quality Systems, the developer of the tool and a trusted partner of Greenlight Guru.

This powerful tool is crafted to streamline your compliance with the latest FDA cybersecurity requirements. It's more than just a checklist; it's a roadmap to securing your medical devices effectively and efficiently.

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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.

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