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More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Featured Capabilities:

Document Management Product Development Design Control Risk Solutions Training Management CAPA Management

Experience the #1 QMS software for medical device companies first-hand. Click through an interactive demo.

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Data collection and management designed for MedTech clinical trials.

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Featured Capabilities:

Electronic Data Capture (EDC) Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys

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Learn valuable, career-boosting skills for the Medical Device industry. Get access to hundreds of free resources as well as subscription-based courses and certifications.

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FREE ON-DEMAND WEBINAR

Understanding The Medical Device Single Audit Program (MDSAP) & How To Prepare For It

The Medical Device Single Audit Program (MDSAP) is an international initiative spearheaded by the International Medical Device Regulatory Forum (IMDRF) to develop a standardized global approach to auditing and inspecting of medical device manufacturers that will be accepted by multiple regulators to address QMS/GMP requirements.

After a multi-year pilot program ended in December 2016, the formal program began implementation at the beginning of 2017.

Although the program has seen relatively low participation to date, the promise to help reduce compliance cost for device makers by eliminating the need for multiple quality system audits and inspections means there is much to be gained by industry from a successful implementation the program.

In our upcoming free 60 minute webinar lead by Kyle Rose, President of Rook Quality Systems, you will be given a thorough overview of the program to understand its many potential benefits to manufacturers, and how your device company can begin preparing for implementation now.

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Specifically, you will learn:
      • Understand the goals and benefits of the MDSAP program
      • What are the main differences between MDSAP and standard auditing
      • How to benchmark your QMS against the MDSAP
      • How the new non-conformance grading system works
      • How to prepare your company for a successful MDSAP implementation
Who Should Attend?
      • Medical Device Executives
      • Regulatory Affairs Professionals and Management
      • Quality Professionals and Management
      • Clinical Affairs Professionals and Management 
      • R&D Engineers and Management

Hosted by

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Presenter: Kyle Rose

President, Rook Quality Systems
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Moderator: JON SPEER

Founder & VP QA/RA, Greenlight Guru

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About Rook Quality Systems

Rook Quality Systems provides specialized and custom consulting services for all classes of medical devices. We work with you to outline your quality and business goals to develop innovative and efficient practices that improve compliance and profit. You can see a full list of the service offerings from Rook Quality Systems by visiting their website to learn more.

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About Greenlight Guru

Greenlight Guru is the only Medical Device Success Platform (MDSP) for companies to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based software, Greenlight Guru is easier to implement, easier to use and designed to fit all medical device needs to enable innovative, safe and effective, True Quality medical devices. Visit our homepage to learn more.

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