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Mia-Care P4SaMD
04 — WHISPER

Smart Assistant (Whisper)

Regulatory expertise, always available in your workflow.

Deterministic rule engine plus LLM policy engine for regulatory compliance. Aligned with MDR, IEC 62304, ISO 14971, FDA, EU AI Act, GMLP, and PCCP. Active compliance intelligence embedded in every SDLC phase.

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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, ISO 14971, FDA, EU AI Act, GMLP, and PCCP. It enforces hard rules, evaluates nuanced compliance policies, and surfaces blind spots 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.

Whisper in Action

Compliance intelligence at the point of engineering

Whisper reads your requirements as you write them, surfacing regulatory gaps before they become audit findings.

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Requirements
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Mia-Care Dev›App Cardio-Monitor›Requirements
Software Requirements Specification
Cardio-Monitor App · v2.1 · IEC 62304 §5.2
Initializing Whisper…
SRS-001The system shall continuously monitor ECG data and classify cardiac rhythms using an AI inference model.
SRS-002The system shall alert clinicians within 3 seconds of detecting a life-threatening arrhythmia event.
SRS-003The AI model shall log all inference outputs with a UTC timestamp and a confidence score.
SRS-004The system shall support FHIR-compliant export of diagnostic reports to connected EHR systems.
SRS-005The AI model shall achieve a minimum sensitivity of 97% on the clinical validation dataset.
✨Whisper AI
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Contextual suggestions
Model: GPT-4 ▾
Cardio-Monitor · dev
Reading requirements…
Ask Whisper…
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.

Directive 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

Whisper understands the full context of what is being built, identifying downstream risks, flagging optimization opportunities, and recommending 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 the specific IEC 62304 guidance for that safety class, not a generic reminder.

Standards Addressed

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

ISO 13485IEC 62304ISO 14971EU MDR 2017/745FDAEU AI ActGMLP
Related Use Cases

See it in action.

For Pre-Market Startups & Scaleups

SaMD Greenfield Development

Building a SaMD from scratch means two simultaneous challenges: writing the software and satisfying the regulator. P4SaMD makes them the same phase.

Read Use CaseFor AI-Native SaMD Enterprise

Building High-Risk AI Software (CDSS)

AI-based clinical software evolves dynamically, but traditional compliance models assume requirements are static. P4SaMD decouples your engineering velocity from regulatory rigidity.

Read Use CaseFor MedTech Giants & Life Sciences Enterprises

Legacy Regulated Software Remediation

Regulatory debt is locking your legacy software. P4SaMD clears the path to certification, without rebuilding from scratch.

Read Use Case
Pricing

Find the right plan for your team.

From your first SaMD to enterprise-scale multi-product compliance — P4SaMD grows with you.

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