New AI Insights in EU Healthcare: Opportunities & Challenges
Healthcare systems are facing a rising demand due to aging populations, an increase in chronic and complex conditions, growing costs,…
Resources & News
Stay informed with real-time regulatory news and expert insights, and keep the conversation going by connecting with us on social media.
Showing 1–9 of 12
eSTAR Guidelines for Successful FDA Submissions
All medical devices seeking to market into the US may require multiple submissions of various types to the Food and…
AI and Machine Learning in Medical Device Regulatory Compliance
Artificial intelligence (AI) and Machine Learning in regulatory compliance is a rapidly advancing field within the science and technology sector.
Navigating Compliance with AI and Machine Learning in SaMD
The medical device industry continues to grow and evolve, becoming increasingly reliant on technology, making software a crucial component of…
RAPS Convergence 2024: MedEnvoy Key Takeaways
From September 17th to 19th, 2024, the MedEnvoy team attended RAPS Convergence 2024. This event brought together regulatory affairs…
Guiding Principles for Medical Devices: AI and Machine Learning
Nearly three years have passed since the US FDA, Health Canada, and UK MHRA jointly identified ten guiding principles in…
Software as a Medical Device (SaMD) EU MDR Compliance
Navigating the realm of Software as a Medical Device (SaMD) within the EU Medical Device Regulation (MDR) can be a…
Medical Device Risk Management: Hazards and Controls
In the ever-evolving landscape of medical technology, ensuring the safety and reliability of medical devices is paramount and even…
MHRA Guidance on SaMDs: Navigating the Regulatory Landscape
Software as a Medical Device (SaMD) is defined as software intended to be used for one or more medical purposes…
Showing 1–9 of 12