08 — GUIDED

Guided Workflows

Compliance guardrails for every developer on your team.

Provides guided, step-by-step workflow assistance and conversational support that keeps engineering teams on the right path through every phase of the SDLC, without requiring deep regulatory expertise to stay compliant.

What It Does

The structure that keeps compliant development on track.

Even experienced engineering teams building SaMD face the same structural risk: without clear guardrails, compliant processes drift. Steps get skipped under delivery pressure. Artifacts get documented after the fact.

Guided Workflows provides step-by-step, contextual structure through every phase of the IEC 62304 lifecycle, keeping teams on the correct path regardless of their regulatory background. A conversational interface answers compliance questions in plain language. Role-specific workflows surface the right scope for each contributor.

Key Features

Step-by-step Process Guidance

Walk through every lifecycle phase

Guides teams through each SDLC lifecycle phase with contextual instructions, decision prompts, and required artifact checklists, so the correct process is always the path of least resistance.

Conversational Interface

Ask in plain language, get regulatory answers

A natural language interface for compliance questions. Developers ask what they need to do, the system responds with specific, actionable compliance answers without requiring them to know the underlying regulations.

Role-based Guidance

Workflows tailored by role and responsibility

Developer, QA, and regulatory affairs workflows each surface appropriate scope and depth. Developers see implementation-level guidance, QA sees verification requirements, RA sees submission-level documentation tasks.

Onboarding Accelerator

From zero SaMD knowledge to compliant delivery

Structured onboarding path for teams new to SaMD development, compressing the learning curve from months to days through guided task sequences, contextual regulation explanations, and milestone checklists.

Standards Addressed

Built to satisfy the standards that matter most to your auditors.

ISO 13485IEC 62304EU MDR 2017/745FDA

Related Use Cases

See it in action.

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