Why paper based systems no longer make the cut
Transition to digital is more important than ever. Read thoughts of our COO Alex Condon and others think why paper based systems no longer make the cut
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Galen Data gets HITRUST recertified
Galen Data is proud to announce that we’ve been recertified HITRUST Risk-Based, 2-year (r2), for our Galen Cloud Platform hosted on Amazon Web Services (AWS). This certification elevates Galen Data into an elite echelon of global organizations when it comes to cybersecurity. HITRUST incorporates an array of federal and state regulations, standards, an
Galen Data is Successfully Certified to ISO Standards
Galen Data was awarded the ISO 13485:2016 certification following the successful completion of its quality management system audit by global certification firm ECM in late November 2018. The audit ensures compliance with the latest version of the internationally recognized ISO standard. Press Release: Press Release – ISO Certification ISO Certificate:
FDA Guidance on Cybersecurity in Medical Devices
On September 26, 2023 FDA issues final guidance on Cybersecurity in Medical Devices: Quality System Consideration and Content of Premarket Submissions. This final guidance follows the draft guidance issues in 2022 and FDA’s Refusal To Accept policy issued in March 27 2023. The new Cybersecurity guidance replaces the 2014 guidance and is much more detailed [&h
Importance of Software Requirements in Product Development
Hear our CEO Chris DuPont, and John Speer, VP of Quality and Regulatory at Greenlight Guru on why Requirements are super important in all facets of product development for medical devices.
