Navigating FDA & IEC 62304 with Agility: A Practical Guide

Navigate the complexities of developing MedTech software while ensuring regulatory compliance and adaptability

In the fast-paced world of digital health, embracing a Compliant Agile approach is not just a strategic choice—it's an enabler for patient-centric innovation. As manufacturers of MedTech software and Software as a Medical Device (SaMD), we have the unique responsibility of weaving cutting-edge technology with strict regulatory standards.

You will learn:
- How Agile Scrum events can align with IEC 62304 clauses, ensuring compliance and agility,
- Step-by-step process how IEC 62304 can be addressed within the Agile framework,
- How to ensure each release and user story meets regulatory standards.