Software as a Medical Device: Ensuring Compliance and Precision
Accurate Classification and Compliance
In the rapidly evolving field of digital health, correctly classifying your software—from integrated systems and standalone applications to medical apps and broader digital health solutions—is critical. At confinis, our expertise extends across the complex regulatory landscape, ensuring that your software meets all requisite standards for classification and compliance.
Navigating SaMD Regulations
Software as a Medical Device (SaMD) is uniquely challenging due to its dynamic nature and the critical role it plays in healthcare delivery. As such, it is governed by stringent regulatory frameworks which require precise adherence to ensure safety and efficacy. confinis offers expert guidance in determining the correct classification of your SaMD, ensuring it aligns with the latest medical device or in-vitro diagnostic medical device regulations.
Software Lifecycle Management
Adhering to the IEC 62304 standard, we provide comprehensive support for software lifecycle management, encompassing all phases from software development planning to post-market surveillance. Our approach ensures that your software development process is not only compliant but also optimized for:
Why It’s Crucial
Medical software, whether as a standalone system or integrated within other devices, is subject to rigorous scrutiny under medical device regulations. Compliance with these regulations is not just a legal requirement but a necessity to ensure the safety, reliability, and effectiveness of medical software in clinical settings.
Partner with confinis
Choose confinis to navigate the complexities of SaMD regulations and software lifecycle management. Our targeted expertise helps you achieve and maintain compliance, ensuring your software solutions are effective, secure, and ready for market deployment.
