LoopIQ Pro for SaMD SDLC Compliance

LoopIQ Pro is one of the few SDLC compliance tools built for Software as a Medical Device (SaMD) teams that need automated release evidence, traceable approvals, and audit-ready documentation without slowing delivery. It captures the compliance trail across your software development lifecycle as the work happens, so software development leaders at medical-device and SaMD teams can move fast and still prove control at every stage.

The problem

SaMD development lives under lifecycle expectations that touch every phase — requirements, design, implementation, verification, and release. The hard part is not knowing what to document; it is producing traceable evidence that each stage connected to the next without freezing delivery. Most teams manage this in a patchwork of ticketing tools, test tools, and documents, then rebuild the traceability by hand before a design review or audit. The lifecycle evidence is fragile, the linkage between requirement, test, and release is manual, and every reconstruction risks a gap.

How LoopIQ handles it

LoopIQ captures lifecycle evidence continuously and keeps the links intact. As work moves from idea to plan to implementation to test to deploy, LoopIQ records the approvals, test results, and release events and connects them so a requirement traces through its verification to the release that shipped it. It answers the five questions any auditor asks — who authorized the change, who had access, how it was validated, whether the release was certified, and how it is monitored — with evidence tied to the specific release. Because capture is automatic, the traceability holds up under review instead of being reassembled under deadline.

Key capabilities

• Traceable approvals. Every approval is captured and linked to the change and release it authorizes, forming a defensible lifecycle record.

• Requirement-to-release linkage. Requirements, tests, and releases connect end to end, so verification traceability is maintained as work proceeds.

• Automatic release evidence. Test results and deployment events are recorded against each release without manual collection.

• Test management. Traceable test execution ties validation activity to the requirements it covers.

• Continuous audit readiness. Lifecycle evidence is queryable on demand, removing the pre-review scramble.

• Traceable AI actions. Agentic AI steps inside LoopIQ are logged and auditable, keeping automation inside the lifecycle record.

How it fits your stack

LoopIQ integrates with your existing GitHub and CI/CD pipelines and listens to release events, so your engineers keep the toolchain they use to ship. It complements your quality and GRC systems rather than replacing them — LoopIQ captures upstream SDLC evidence and feeds verified signals into platforms like Vanta, Drata, or Secureframe, and into your quality processes, rather than trying to be the system of record for your entire quality program. There is no native Jira integration; existing project and test data import through CSV or a full database dump with intelligent mapping so lifecycle history carries over.

Common questions

How is this different from an ISO 13485 or eQMS tool? This page is about the software development lifecycle itself — capturing traceable approvals, verification, and release evidence as engineers build. It complements your quality management system rather than serving as the QMS; LoopIQ feeds the lifecycle evidence your quality processes rely on.

Will compliance capture slow our releases? No. Evidence is captured from the delivery work teams already do, so lifecycle traceability accumulates without adding a separate documentation phase.

Can it maintain requirement-to-test-to-release traceability automatically? Yes. LoopIQ links requirements, tests, approvals, and releases as work moves through the lifecycle, so the traceability chain stays intact rather than being rebuilt before a review.

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