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:

  • Development and Testing

    Implementing structured and systematic processes to ensure high-quality software output that meets all clinical and regulatory requirements.

  • Documentation

    Carefully compiling and maintaining essential documentation that meets regulatory scrutiny and supports the overall development lifecycle.

  • Cybersecurity and Data Protection

    Integrating robust cybersecurity measures and data protection protocols from the outset to safeguard patient data and comply with global data privacy regulations.

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.