Securing the CE Mark in the EU Advanced Medical Device Market
Uncertain about navigating the EU MDR and securing your CE Mark? This guide simplifies the process for advanced medical device companies. Learn key insights and how Galen Data can help.
Speed to Market and Compliance in Medical Device Development
Bringing your life-saving medical device to market quickly is a balance of speed and compliance. Learn key strategies & avoid common pitfalls to achieve both!
Medical Device Data at Scale: Storage and Security from MVP to Marketplace
Medical device data is increasing exponentially! Learn how to strategically plan for storage & scaling data from MVP to market with Galen Data’s expert guidance.
New FDA Regulations on Artificial Intelligence and Machine Learning in Medical Devices
Explore the crucial FDA updates on AI and ML in medical devices. Learn how these changes affect safety, efficacy, and the future of healthcare technology.
An Early Report: How AI Will Influence Advanced Medical Devices
The rapid advancement of Artificial Intelligence (AI) is revolutionizing technology, and the advanced medical device sector is one of the most exciting areas of innovation. AI is poised to make significant strides in influencing advanced medical devices and reshaping healthcare delivery’s future. The graphic below from a 2022 published paper in Nature Med
How to Proactively Manage Risk for Advanced Medical Device Manufacturers
Advanced medical devices are revolutionizing patient outcomes by providing innovative solutions to challenging conditions. Even so, regulatory agencies and advanced medical device companies are fully aware that devices can pose significant patient risks in the product life cycle from faulty design, development, or manufacturing. Proactively managing risk is cru
FDA Cybersecurity Guidance
The Internet of Things (IoT) has revolutionized healthcare for several years. The challenge is that connected devices send data across networks to databases, all of which may be vulnerable to cyber attacks if they are not adequately secured. Advanced medical devices also need to be maintained and updated. Some aging devices represent technical debt for [&hellip
Software Bill of Materials for Advanced Medical Device Development
It’s hard to imagine the world of medical technology before computers when medical devices were tangible gadgets everyone could see and touch. Enter the computer age, which quickly led to using software in medical device development. Software innovation continues to increase with significant growth in the Software as Medical Device (SaMD) sector. Understa
Meet Top 6 Companies in Medical Device Security Services
As medical device technology advances, so does the need for robust security measures to protect patient data and prevent unauthorized access. All stakeholders in the advanced medical device space know that the news is not good. According to The HIPAA Journal, in 2018 healthcare data breaches of 500 or more records had a rate of […]
Managing Downside Risks After Launch – Post Market Best Practices for Connected Medical Devices
When advanced medical device (AMD) startups are in the thick of device design and development, getting to market is the light at the end of the tunnel. While Go To Market (GTM) approval is a huge milestone, a market launch is simply the start of an even longer marathon that doesn’t end until the device […]
