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
FDA Guidance on Real World Data
In December 2023 FDA Issued a final guidance document on Assessing real world data registries to support regulatory decision making for Drug and Biological Products, which provides considerations when designing a registry or using an existing registry to support a decision about a drug’s effectiveness or safety Learn more here
Galen Data wins Best Software Solution Provider of the Year at Med-Tech World
The Galen Data team was humbled to be among the great nominees in the Software category at the Med-Tech World Conference in Malta. This award is a testament to the hard work and commitment of our team and isn’t just a company achievement; it reflects the drive and daily effort of everyone, including our supporters and […]
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 This final guidance follows the draft guidance issues in 2022 and FDA’s Refusal To Accept policy issued in March 27 2023.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
FDA Draft Guidance for AI/ML
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as Software as a Medical Device (SaMD) or as FDA calls it machine learning enabled software functions (ML-DSFS)In this draft guidance FDA lays out a new plan that can be submitted during your initial applications […]
Galen Data Achieves HITRUST Risk-based, 2-year Certification to Further Mitigate Risk in Third-Party Privacy, Security, and Compliance
Houston, TX, (June 9th, 2022): Galen Data, Inc. a leading provider of medical device cloud data storage, today announced the Galen Cloud hosted on Amazon Web Services has earned Certified status for information security by HITRUST. The frequency and sophistication of cyber-attacks is increasing at an alarming rate. The healthcare industry is no exception as [
Galen Data featured on AWS Startup Blog
‘Build on the shoulders of giants’, they said. And that’s exactly what we did. Read about how we leverage the services that AWS provides to create a scalable cloud platform to connect our client’s #MedicalDevices. Our decades of combined medical device and cloud development experience and careful work configuring its infrastructure is what h
Medical Device Cloud Connectivity Whitepaper | Galen Data
Galen Data Inc., announces the release of a 28-page whitepaper entitled “The Definitive Guide to Medical Device Connectivity” which offers in-depth guidance on device-to-cloud connectivity for medical device companies. The guide is co-authored by a team of leading experts in medical device design and development, who have a combined 50+ years of experience
Life-saving Device with Turnkey Cloud Connectivity | Galen Data
Galen Data Inc. and HeartHero, Inc. are proud to announce a partnership that will accelerate the commercialization of HeartHero’s life-saving emergency medical device. HeartHero, headquartered in Denver, CO, has developed a first-of-its-kind “smart” Automated External Defibrillator (AED) and is poised to deliver with Galen Data’s turnkey cloud platform
UK-based Startup Chooses Galen Data’s Cloud Platform
Altair Medical aims to revolutionize care for respiratory symptoms and diseases with its advanced, cloud-based respiratory monitoring sensors. Their technology has earned FDA Breakthrough Medical Device designation. Recently, Altair Medical decided to transition to Galen Data’s cloud platform to accelerate development for a commercial product. Monitoring Re
