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[Podcast] Implementing Changes to SaMD under new EU MDR

September 6, 2019

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[Podcast] What are the regulatory expectations for Software as a Medical Device (SaMD)?

This podcast was hosted by Andrew Wu, the Software Consultant of Rook Quality Systems. You will find this podcast helpful for understanding how Rook helps SaMD companies ensure that their documentation, platform, and systems they establish during the design, development, and manufacturing of software aligns with regulatory requirements. Link to the Podcast: https://www.greenlight.guru/blog/what-are-the-regulatory-expectations-for-software-as-a-medical-device-samd Please contact us at info@rookqualitysystems.com if you have any questions. Sponsored by #SaMD #IEC62304 #IMDRF #DigitalHealthSoftwarePrecertProgram

[Webinar] How to conquer Supplier Management for Medical Device companies

This webinar was hosted by Kyle Rose, the President of Rook Quality Systems. You will find this webinar helpful for understanding purchasing and supplier control process detailed in the ISO 13485/ 21 CFR820/ MDSAP/ MDR regulation. Specifically this webinar will cover: - Upcoming changes in ISO 13485 and 21 CFR 820 to meet MDSAP and MDR requirements - How to create an effective supplier evaluation process - Incorporating risk into supplier evaluation and review - Best practices for efficient supplier management - How quality affect Supplier Agreements Link to the Webinar: https://www.greenlight.guru/webinar/conquer-supplier-management Please contact us at info@rookqualitysystems.com if you ha

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