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Mia-Care P4SaMD
08 — GUIDED

Guided Workflows

Compliance guardrails for every developer on your team.

Provides guided, step-by-step workflow assistance and a conversational AI compliance assistant that keeps engineering teams on the right path through every phase of the SDLC — combining deep regulatory framework indexing with real-time access to project data, without requiring deep regulatory expertise.

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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 specialized compliance assistant acts as the project's knowledge core — combining deep indexing of the applicable regulatory framework with real-time access to uploaded documentation, integrated tools, and implementation data. Role-specific workflows surface the right scope for each contributor.

In Action
Dashboard
SDLC
Workflow Guide
Requirements
Software System
Verification
Risk Analysis
Configuration
Product Metadata
Regulatory Framework
AI Agents
Users
Settings
Mia-Care Dev›AI Diagnostic Tool›Workflow Guide
SDLC Workflow Guide
Step-by-step guidance for IEC 62304 compliant software development
⚠ Action Required3 Priority Tasks
The following tasks require immediate attention to keep the project on track.
CRITICALBLOCKERDefine Risk Control Measures
Requirements & Risk Analysis · Overdue · 2 days
CRITICALBLOCKERDocument each module in detail
Architecture & Detailed Design · Due today
HIGHList all third-party libraries and assess their safety
Architecture & Detailed Design · 2–3 days
AI Diagnostic Tool
Phase 3 of 6 · 8 of 29 tasks completed
In DevelopmentIEC 62304 Glossary
SDLC Phases

Real-time compliance dashboard — priority blockers and overdue tasks surface automatically with IEC 62304 section references. Critical issues are resolved in place, keeping the whole team aligned without leaving the workflow.

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.

Compliance Assistant

Project-aware compliance intelligence, always in context

A specialized conversational AI engine that combines deep indexing of the applicable regulatory framework (IEC 62304, MDR, ISO 14971, and others) with real-time access to project data — uploaded documentation, integrated tools, and implementation. Supports complex cross-entity queries and delivers context-specific guidance that ensures project-wide consistency and compliance.

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.

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

Many organizations hold valuable legacy software trapped by regulatory debt. P4SaMD provides a structured 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.

StandardSmall teams
ProfessionalGrowing teams
UnlimitedEnterprise
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