SaMD Strategy
At QC Analytics, we support organizations in defining and implementing a complete Software as a Medical Device (SaMD) strategy, combining GAMP5, IEC 62304, and regulatory strategy into a unified, compliant, and scalable approach.
Developing medical device software requires more than coding — it demands a structured framework that ensures compliance, safety, and audit readiness across the entire lifecycle.
What is SaMD Strategy?
A SaMD strategy is a structured approach that aligns software development practices, quality systems, and regulatory requirements with your business objectives.
It ensures that your software:
- Meets applicable standards (IEC 62304, GAMP5, FDA, MDR)
- Is developed within a controlled and traceable lifecycle
- Can successfully pass audits and regulatory submissions
GAMP5-Based Development Approach
We help you implement GAMP5 (Good Automated Manufacturing Practice) principles to ensure your systems are fit for intended use and compliant with GxP regulations.
Our approach includes:
- Risk-based validation of software and systems
- Definition of user requirements and functional specifications
- Supplier and tool assessment
- Configuration and change management processes
- Full traceability from requirements to testing
GAMP5 promotes a risk-based, lifecycle-driven methodology that improves quality while optimizing validation effort.
IEC 62304 Software Lifecycle Compliance
We support the implementation of IEC 62304, the international standard defining the software lifecycle for medical devices.
Our services cover:
- Software lifecycle planning and documentation
- Software safety classification (Class A, B, C)
- Architecture and design documentation
- Verification, validation, and testing processes
- Maintenance, change control, and release management
IEC 62304 ensures that software is developed and maintained through controlled, traceable, and risk-managed processes across its lifecycle.
Building Internal Processes for Compliance
Beyond standards, we help you operationalize compliance by building and optimizing your internal processes.
We support:
- Establishment of Software Development Life Cycle (SDLC) aligned with IEC 62304
- Integration with Quality Management Systems (ISO 13485)
- Risk management integration (ISO 14971)
- Documentation frameworks and templates
- Traceability systems linking requirements, risks, and tests
- Audit readiness and inspection preparation
This ensures your organization has repeatable, scalable processes that support both development and regulatory expectations.
Regulatory Strategy Integration
A strong SaMD strategy must be aligned with a clear regulatory pathway.
We help you:
- Define a regulatory strategy aligned with your business goals and target markets
- Prepare technical documentation for CE marking and FDA submissions
- Develop Quality Management Systems (ISO 13485)
- Perform hazard analysis and risk management
- Plan market entry and compliance roadmaps
A well-defined regulatory strategy ensures your product is compliant, competitive, and ready for approval.
The Next Steps
Contact QC Analytics to define your SaMD Strategy and build a compliant, efficient, and future-ready software development framework tailored to your organization.