MDSAP vs. ISO 13485:2016 Gap Assessment Checklist

This multipurpose resource has built-in functionality to assess quality system requirements of the ISO 13485:2016 standard alongside the specific requirements of each auditing organization participating in MDSAP, allowing medical device companies to identify gaps within their QMS processes and track subsequent changes throughout implementation.

Features & Benefits

✓   Helpful overview between the gaps and your processes
✓   Shows "risk grading" of each MDSAP requirement
✓   Inclusive status tracking during the implementation phase
✓   Easy to sort by regulatory authority in MDSAP
✓   Reusable tool to prepare for MDSAP audits

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3 Things You Need to Know About the
Medical Device Single Audit Program (MDSAP)

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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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About Regulatory Globe

To develop medical products that improve quality of life and extend life expectancy is the goal of the medical device industry. In order to serve this basic need optimally, laws and regulations are inevitable. Such regulations ensure safety and quality of products as well as raise the state of the art and thus promote progress steadily. This is the reason why it is so important to take the new requirements as an opportunity for improvements and not as a burden. Only companies that recognize this will be successful in the long term.

This is where the task of Regulatory Globe begins. Together with our partners, we specialize in monitoring laws and regulations and provide tools that help our clients improve their products processes. This will eventually benefit the people in need of these medical devices.

Visit their website to learn more.