FDA Releases “Transparency of Machine Learning – Enabled Medical Devices: Guiding Principles” Published: June 26, 2024 View
Medical Device Software: Considerations for Device and Risk Characterization Published: April 2, 2024 View
Revolutionizing Healthcare: The Rise of Medical Device Software and EU Regulatory Compliance Published: March 26, 2024 View
FDA Releases “Predetermined Change Control Plans for Machine Learning – Enabled Medical Devices: Guiding Principles” Published: October 30, 2023 View
FDA Releases Long-Awaited Final Guidance for Clinical Decision Support Software Published: September 30, 2022 View
Digital Health Software Pre-Certification Update: Final FDA Report Revealed Published: September 28, 2022 View
FDA Reissues Draft Guidance, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” Published: April 12, 2022 View
FDA Releases Draft Guidance: Content of Premarket Submissions for Device Software Functions Published: November 3, 2021 View
U.S. FDA Releases Artificial Intelligence and Machine Learning Action Plan Published: January 18, 2021 View
CE Marking of Digital Health Technologies: Stricter Rules for Medical Device Software under the EU MDR Published: April 24, 2018 View