Plan
Safety class, lifecycle plan and traceability ready for audits and submissions.
SaMD & IEC 62304
Software lifecycle and risk aligned to 62304 and real use
Build lifecycle documents, traceability and software risk that match your device, safety class and markets. Reviewers find a clean path from requirements to tests and evidence.
Right device classification
Device claims and intended use of SaMD mapped to Class A, B or C
Device claims and intended use of SaMD mapped to Class A, B or C
Traceability
Requirements mapped to tests and risk controls
Requirements mapped to tests and risk controls
Audit ready
Evidence becomes easy to sample and verify
Evidence becomes easy to sample and verify
AI/ML awareness
Create, update, and maintain data with risks handled clearly
Create, update, and maintain data with risks handled clearly
Scope
What we execute and what you receive
We connect lifecycle, risk and evidence so your software story is complete and consistent across records and submissions.
Lifecycle activities we run
- Classification of software safety class and regulatory strategy
- Lifecycle plan, configuration management and change control
- Requirements, architecture, detailed design and unit strategy
- Software risk with links to ISO 14971 and cybersecurity
- Verification and validation planning and reports
- Problem resolution and anomaly handling process
- Usability links and human factors considerations
- Supplier controls and tool qualification as needed
- Release, maintenance and post market processes
Deliverables you bring to audit and submissions
- Lifecycle plan and procedures sized to class
- Requirements set with bidirectional traceability
- Architecture, design and risk files with controls
- Verification and validation protocols and reports
- Cybersecurity documentation aligned to markets
- SOUP and supplier listings with controls
- Change control records and release notes
- AI/ML change and data management approach if applicable
How it works
From plan to verified release step by step
We align activities with your device and team so each sprint builds records that stand up to review.
Build
Requirements, design and tests linked with risk and cybersecurity controls.
Release
Verification, validation and release records complete with clear links.
FAQ
Common questions
How do we set the software safety class?
We assess hazards and possible harm to establish A, B or C and size activities accordingly.
Can you work with our agile process?
Yes. We map lifecycle and evidence to your sprints and tools to keep velocity and compliance aligned.
How is cybersecurity handled?
We link threat models and controls into risk, requirements and tests to meet market expectations.
Do you cover AI or ML changes?
Yes. We define data, update and monitor approaches that keep performance and safety under control.
Ready to align software with 62304?
Book a quick call to align deliverables, roles and dates so your next release is audit ready.