Practical support inside your quality system
We work within client quality processes, supporting the records around software design, verification, changes and release. This can include preparing design-review material, linking requirements and verification evidence, drafting release notes and addressing review feedback.
Our hands-on eQMS experience includes Greenlight Guru and ins2outs. We work in the tools and approval processes agreed for your engagement.
Connect records to the work
An engineering change can affect multiple pieces of evidence. We help make those connections visible so the product team, reviewers and release owners have a shared view of what changed.
- Support requirements and design documentation.
- Connect verification records and design-review evidence.
- Prepare change and release documentation for review.
- Improve repeatable record preparation and filing workflows.
- Support handover so the next release builds on the last.
Approvals stay with the people assigned that responsibility in your quality system. Automation can help prepare or file records; it does not replace the required review.
Bring experience from the audit room
Our team has participated in ISO 13485 audits for companies developing Class II and Class III software medical devices. We have answered auditors’ questions and provided evidence to substantiate our work.
That experience informs how we support your team before and during an audit. We can organize the software records, connect requirements to verification and help explain the decisions behind an implementation or release. We work with the people who own your quality system and its audit responses.
Work alongside the right specialists
Your regulatory and quality specialists can lead strategy, clinical validation and submissions. Where additional expertise is needed, specialist partner involvement is separately scoped. We define the division of responsibility before the work starts.
Our team’s training includes completed basic awareness courses in ISO 13485:2016 quality management and ISO 14971:2019 medical-device risk management.
Build a useful starting point
Bring us the product stage, the quality environment and the delivery problem you need to resolve. We can help shape a scoped workstream that connects engineering execution with the evidence around it.