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AI Medical Devices: Answering Your Burning Questions
As artificial intelligence continues to revolutionize medical device development, the FDA’s evolving regulatory framework presents both opportunities...
Software Development
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Navigating FDA’s Latest Guidance Updates for AI-Enabled Medical Devices: A Marketing Submission Guide
As artificial intelligence transforms healthcare innovation, the FDA continues to evolve its regulatory framework for AI-enabled device software...
1 min read
Playing Defense: Cybersecurity for Diagnostic Devices
No industry or device is immune from the risk of cyber attacks. And it’s especially important that medical devices including diagnostic instruments...
2 min read
Ensuring Compliance with New FDA Guidance on Software Documentation & Cybersecurity
New guidance from the FDA replaces similar, but now obsolete, guidance. Some of the guidance was issued in response to the PATCH Act, which is a 2022...
5 min read
Artificial Intelligence (AI), General Data Protection Regulation (GDPR) and Cybersecurity: 10 Misconceptions About Medical Device Software
Medical Device Software (MDSW) is a growing, fast-evolving industry. However, manufacturers must often face a regulatory framework which does not...
3 min read
Agile vs. Regulatory: How the Two Coexist and Contribute to Successful Medical Device Software Development
Software is gaining relevancy in a broad range of medical devices, as it either enables the control or influence of their operation, or because...