Smart Assistant (Whisper)
Regulatory expertise, always available in your workflow.
A deterministic rule and LLM-based policy engine for regulatory compliance. Whisper is aligned with MDR, ISO 13485, IEC 62304, ISO 14971, FDA, and AI regulatory frameworks (EU AI Act, GMLP, PCCP). It delivers active, pre-configured regulatory intelligence throughout the SDLC and performs AI-driven assessments of requirement quality and test coverage — identifying blind spots before they become audit findings.
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, and the latest AI-related regulations and guidances (EU AI Act, GMLP, and PCCP). It enforces hard rules, evaluates nuanced compliance policies, and performs AI-driven assessments of quality. It addresses compliance gaps and targets 100% verified software by surfacing blind spots in the verification process 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.
Compliance intelligence at the point of engineering
Whisper reads your requirements as you write them, surfacing regulatory gaps before they become audit findings.
Standards Addressed
Built to satisfy the standards that matter most to your auditors.
See it in action.
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 EnterpriseBuilding 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 EnterprisesLegacy Regulated Software Remediation
Many organizations hold valuable legacy software trapped by regulatory debt. P4SaMD provides a structured path to certification without rebuilding from scratch.
Read Use CaseFind the right plan for your team.
From your first SaMD to enterprise-scale multi-product compliance — P4SaMD grows with you.
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