SaMD developers operate in a fast-paced, agile world, but the medical device industry is governed by the structured ISO 13485 standard. This episode demystifies how to merge these two worlds, transforming compliance from a roadblock into an integrated part of your development lifecycle. We explore practical, real-world strategies to build a robust Quality Management System that satisfies regulators without sacrificing the speed and flexibility essential for innovation in digital health.

Imagine a promising SaMD startup with a revolutionary diagnostic algorithm. They operate in two-week sprints, pushing updates constantly. But when they prepared for their first regulatory audit, they hit a wall. Their documentation was scattered, their design controls didn't align with their sprint-based workflow, and the auditor was questioning their risk management process. They faced significant delays and rework, threatening their market entry. This episode addresses exactly how to avoid this scenario.

Key Takeaways This Episode:

- How can the rigid structure of ISO 13485 design controls be adapted for an iterative agile backlog?

- What does a "definition of done" look like in a regulated agile sprint?

- How do you conduct continuous risk management (ISO 14971) within each development cycle?

- Which tools can automate QMS documentation to prevent it from slowing down development?

- When is the right time to perform software validation in a CI/CD pipeline?

- How do you manage changes and document updates for a SaMD that is constantly evolving?

- What are the key differences in applying ISO 13485 to a standalone SaMD versus software embedded in a physical device?

- How can you prove to an auditor that your agile process is under control and compliant?

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