04 — WHISPER

Smart Assistant (Whisper)

Regulatory expertise, always available in your workflow.

A regulatory intelligence engine aligned with MDR, ISO 13485, IEC 62304, FDA guidance, EU AI Act, GMLP, and PCCP requirements. Whisper enforces deterministic rules, evaluates complex compliance policies, and surfaces proactive guidance exactly when developers need it.

What It Does

Regulatory expertise at the point of engineering.

The traditional model concentrates all regulatory expertise in a small team of RA/QA specialists expected to cover every engineering decision in real time. At a certain scale, that model breaks down.

Whisper is a regulatory intelligence engine aligned with MDR, ISO 13485, IEC 62304, FDA, EU AI Act, GMLP, and PCCP. It enforces hard rules, evaluates nuanced compliance policies, and proactively flags issues before they become audit findings. Routine decisions are handled at the point of engineering. RA/QA teams stay focused on where their expertise has the most impact.

Key Features

Deterministic Rule Enforcement

No ambiguity, no gaps

Whisper applies a curated, versioned regulatory ruleset where every enforcement action is traceable to a specific requirement. Binary compliance checks, software classification boundaries, mandatory documentation triggers, all handled consistently, every time.

Policy Evaluation

Compliance judgment for complex decisions

Beyond hard rules, Whisper evaluates complex compliance policies that require contextual analysis, surfacing structured, traceable recommendations so your team makes informed decisions rather than guesses.

Proactive Suggestions

Catch issues before they become findings

Because Whisper understands the full context of what is being built, it identifies downstream risks, flags optimization opportunities, and recommends actions that reduce compliance debt before it accumulates.

Contextual Guidance

Right guidance at the right moment

Whisper surfaces enforcement and suggestions based on what the developer is currently working on. Implementing a Class B software item triggers IEC 62304 5.3 guidance, not a generic reminder.

Standards Addressed

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

ISO 13485IEC 62304EU MDR 2017/745FDAEU AI ActGMLP

Related Use Cases

See it in action.

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