Digital Health solutions, especially those go beyond clinical decision support and into the Software as a Medical Device (SaMD) realm, are different enough from their hardware and traditional device families of products that the FDA has chosen to regulate them using a new pathway. Because they can be deployed more easily and are less expensive to produce, SaMD solutions have a different safety and compliance risk profile. This online education session will dive into unique challenges of applying regulatory science to software-intensive medical devices.
Software systems are not “manufactured” the same way as traditional hardware-focused systems so they cannot meet CGMP and similar manufacturing standards. Software has a well-defined systems development lifecycle and if regulatory science is applied properly to those lifecycle steps SaMD solutions have a chance of being even safer and more compliant than their software+hardware cousins.
Deterministic reproducibility and assurance through what the speaker calls automated RegOps (regulatory operations) is possible by adding more machine instrumentation and real world monitoring. With proper RegOps, SaMD can be safer and its effectiveness can be tested more easily because regulatory artifacts can be generated as a byproducts of the development effort instead of a separate compliance effort.
Here's what you'll learn in this presentation:
• Learn what the differences are between traditional medical device regulation and SaMD regulations.
• Learn what unique and novel risks software-intensive medical devices pose to the healthcare ecosystem.
• Learn about the challenges and opportunities of SaMD versus 510(k) compliance.
• Learn about a new RegOps approach that can allow regulatory artifacts to be generated as a byproducts of the SaMD development effort.
• Learn how automated RegOps could reduce the preparation time for FDA submissions.
• Learn how building regulatory practices directly into the systems development lifecycle could ease the inspection and audit burdens but create more reliable results.