LoopIQ Pro for ISO 13485 SaMD Teams

LoopIQ Pro is ISO 13485 software for Software-as-a-Medical-Device (SaMD) teams that automates release evidence, links delivery signals to quality objectives, and cuts manual audit preparation. It is built for software development leaders at SaMD teams who must satisfy design-control and change-management expectations without turning every release into a documentation exercise. As engineers implement, test, and release, LoopIQ records the evidence your quality system depends on.

The problem

ISO 13485 expects medical device software to show controlled design changes, verification and validation activity, and documented records tying it all together. For SaMD teams shipping on modern release cadences, keeping that record current inside a general-purpose engineering stack is hard: design inputs live in one place, code changes in another, test results in a third, and the QMS in yet another. Reconciling them for an internal or notified-body audit consumes days per release and leaves the quality team dependent on manual recordkeeping.

How LoopIQ handles it

LoopIQ captures the delivery evidence quality teams need and links it to quality objectives, structured around the five auditor questions:

• Change authorization — design and code changes recorded with their approvals.

• Access governance — who could act on the change captured in context.

• Test and validation — verification and validation results tied to the requirements they cover.

• Release certification — a signed record that each release met its quality gates.

• Monitoring and response — post-release signals connected to the change that produced them.

The engineering side of the design-control record assembles itself, reducing the manual bridge between delivery and the QMS.

Key capabilities

• Automated evidence capture — approvals, verification, and deployment signals recorded from GitHub and CI/CD.

• Traceable test management — V&V results link to the design inputs and requirements they satisfy.

• Release certification — audit-ready release records for each SaMD release.

• Change control workflows — design-change authorization and review enforced and logged.

• Unified workspace — requirements, changes, tests, and release evidence in one connected system.

• Traceable intelligence — AI-assisted actions in the workflow remain auditable.

How it fits your stack

LoopIQ is eQMS-adjacent, not an eQMS replacement. Electronic quality systems such as Greenlight Guru, Qualio, or MasterControl remain your system of record for the full quality management system — CAPA, document control, training, risk files. LoopIQ complements them by automating the engineering evidence — design-change, V&V, and release records — and making it available to feed the QMS, so the delivery-to-quality bridge is continuous. It integrates with GitHub and CI/CD and imports existing project data via CSV or a full database dump with intelligent mapping (there is no native Jira integration).

Common questions

Is LoopIQ an eQMS? No. It complements your eQMS by automating the SDLC evidence — design changes, verification, validation, and release certification — that otherwise gets bridged into the QMS by hand.

Does it cover all of ISO 13485? No single tool does. LoopIQ focuses on the software design-control, change, and release evidence within the standard and connects it to your quality objectives; broader QMS elements remain in your eQMS.

How does it reduce audit prep for SaMD releases? By capturing V&V results, design-change approvals, and release records continuously and keeping them linked, LoopIQ replaces the pre-audit reconstruction with a review of evidence that is already assembled.

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