Software Development Life Cycle (SDLC) – IEC 62304 Compliance

MedOrdyn provides structured review and compliance support for Software Development Life Cycle (SDLC) processes aligned with IEC 62304, enabling medical device and Software as a Medical Device (SaMD) manufacturers to establish controlled, traceable, and audit-ready software lifecycle frameworks. Our focus is on evaluating existing processes and ensuring alignment with regulatory expectations across FDA, EU MDR, and global digital health requirements.

Our approach includes a detailed assessment of SDLC processes covering software development planning, requirements management, detailed design documentation, verification, and system testing activities. MedOrdyn identifies gaps between current practices and regulatory expectations and provides structured recommendations to strengthen compliance, documentation quality, and traceability.

A key focus of our services is the alignment of software lifecycle activities with ISO 14971 risk management requirements. We support the linkage between software requirements, identified risks, and implemented control measures, ensuring that safety considerations are consistently addressed within both SDLC documentation and regulatory submissions.

MedOrdyn also supports the review and refinement of essential software documentation required for audits and submissions. This includes software development plans, software requirements specifications, detailed design documentation, verification and validation reports, and traceability matrices. Our focus is on ensuring that documentation is complete, consistent, and aligned with regulatory expectations.

In addition, we provide guidance on software safety classification, documentation expectations, and regulatory alignment to support compliance across multiple jurisdictions. Our services help organizations strengthen their SDLC processes from a compliance perspective and improve readiness for regulatory inspections and Notified Body assessments.