SaMD Lifecycle & Quality Governance

What This Service Covers

End-to-end lifecycle control for Software as a Medical Device (SaMD)
Integration of software development processes with QMS requirements
Control of software releases, updates, and version management
Traceability across software requirements, risk, verification, and validation
Post-market monitoring of software performance and safety

When This Service Is Typically Required

Development or scaling of SaMD products in regulated markets
Transition from non-regulated software development to medical-grade processes
Regulatory submission preparation for software-based medical devices
Strengthening lifecycle controls for existing SaMD products

Applicable Regulations & Standards

IEC 62304
ISO 13485
ISO 14971
IEC 62366-1
FDA and EU SaMD guidance

How This Fits Within the Quality System

SaMD lifecycle activities are governed as part of the QMS, ensuring that software development, risk control, and post-market monitoring are fully integrated within established quality processes.

Contact

Connect with us to align your SaMD lifecycle with regulatory-grade quality system controls.