Smart technologies will continue to play a big role in advancing decision-making efforts. Read to see what we and others think the future of MedTech is and what technology is poised to go main stream in 2019
On April 3, 2023 FDA release guidance around making changes to Artificial Intelligence (AI) and Machine Learning (ML) models categorized as Software as a Medical Device (SaMD) or as FDA calls it machine learning enabled software functions (ML-DSFS)In this draft guidance FDA lays out a new plan that can be submitted during your initial applications […]
Cloud Connectivity – Benefits and Challenges webinar set
The Temple Health and Bioscience District offers a monthly Lunch and Learn webinar series, featuring notable industry speakers. The next Lunch and Learn (noon to 1 p.m. Tuesday, July 30) will feature Abbas Dhilawala, CTO of Galen Data, a cloud platform built for 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 This final guidance follows the draft guidance issues in 2022 and FDA’s Refusal To Accept policy issued in March 27 2023.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
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:
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