Creating Software as a Medical Device (SaMD) Technology: Navigating Regulatory Challenges
Wednesday, 11 September 2024, 05:38
Regulatory Challenges for SaMD Technology
Software as a Medical Device (SaMD) is revolutionizing patient care and treatment modalities. With software playing a pivotal role in diagnostics and therapeutics, regulators are now adapting frameworks to ensure safety and efficacy.
Key Regulations Impacting SaMD
- FDA Guidelines: The FDA is key in managing SaMD regulations, focusing on software safety.
- EU Regulations: Europe introduces unique mechanisms for the approval of SaMD.
- Global Standards: Organizations like WHO are addressing international SaMD compliance.
Significance of Upcoming Xtalks Webinar
The upcoming webinar hosted by Xtalks is designed to provide insights on these regulatory nuances. Attendees can gain valuable knowledge on navigating SaMD development and compliance.
This article was prepared using information from open sources in accordance with the principles of Ethical Policy. The editorial team is not responsible for absolute accuracy, as it relies on data from the sources referenced.