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[Podcast] Implementing Changes to SaMD under new EU MDR

September 6, 2019

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[Podcast] Tips, Tricks, and Best Practices for Complying with ISO13485:2016

Link to the podcast: https://soundcloud.com/medical-device-podcast/tips-tricks-best-practices-for-complying-with-iso-134852016 When it comes to 13485-2016, are you scrambling to meet requirements? Are you trying to figure out the how, what, or when regarding its timeline? Or, maybe you just don’t know what you need to do. You are not alone because a lot of companies are behind. Don’t wait until it is too late. Now is the time to take action. Today’s guest is Kyle Rose, president of Rook Quality Systems, which helps companies achieve 13485 certification by using the Greenlight Guru’s Quality Management Software platform. Kyle shares some tips and tricks for dealing with 13485 because time is

FDA’s take on Digital Health Regulatory Paradigm Shift

In recent years, the medical device industry has become overwhelmingly impacted by digital health. According to the US Food and Drug Administration (FDA), products that fall under this category include devices such as mobile health, health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine. With increased focus on making medical devices “smart,” the FDA worked to define regulations to ensure these devices are safe and effective. During the Health Datapalooza that was held 26-27 April 2018, FDA Commissioner Scott Gottlieb highlighted new initiatives launched by the FDA to support development and adoption of healthcare innovation in the digita

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