freyrsolutionsm

Software Development Lifecycle (SDLC) and Quality Gates for SaMD (Software as a Medical Device) compliance play a critical role in ensuring that healthcare software is safe, effective, and meets strict regulatory standards. In the context of SaMD, the SDLC is not just about building software but about maintaining a structured, traceable, and risk-managed process from concept to post-market monitoring. Every phase—planning, requirements gathering, design, development, testing, deployment, and maintenance—must align with global regulatory expectations such as those from the FDA, ISO 13485, and IEC 62304.