Mia-Care Srl

Compliance by design for Software as a Medical Device.

MedTech and Life Sciences organizations are caught between the need for fast software innovation and the manual burden of regulatory compliance. Engineering and Quality work in separate silos, documentation is reconciled by hand, and certification of AI models or legacy software delays launches by 12 to 18 months.

Mia-Care P4SaMD is an AI-native platform that closes this gap. It unifies eQMS, ALM and Development into a single execution system and embeds regulatory controls directly into the Software Development Life Cycle, turning compliance from a bottleneck into an automated guardrail.

What P4SaMD does

• Orchestrates your existing toolchain (Git, Jira, ALM, eQMS, IDP) into a fully compliant IEC 62304 workflow
• Maps requirements, risks and tests to code and test cases in real time, producing a living Design History File
• Generates audit-ready technical files, risk evidence and verification reports automatically
• Ingests legacy (brownfield) applications, runs automated gap analysis and builds a remediation plan toward certification
• Governs AI-enabled components against EU AI Act, GMLP and FDA PCCP requirements, including model cards and bias assessment
• Guides teams with limited RA/QA expertise through compliant processes with real-time rules, policies and suggestions

Regulatory coverage: EU MDR 2017/745, IVDR 2017/746, FDA QMSR and 21 CFR Part 820, ISO 13485, IEC 62304, IEC 82304-1, ISO 14971, IEC 62366-1, IEC 81001-5-1, EU AI Act, GDPR, HIPAA, EHDS.

Why Mia-Care

• Continuous compliance on a platform validated following GAMP 5 principles
• Modular and adaptable to your existing QMS and engineering culture, no rigid process imposed
• Adaptive regulatory reliability: the platform tracks evolving regulations so your teams do not have to

Outcomes measured in customer projects:

• 3× Faster Time-To-Market
• 50% Development Cost Reduction
• 100% Audit-Ready
• 90% Less Manual Documentation

Mia-Care is part of the Mia-Platform group and serves hospital groups, MedTech manufacturers, pharma and digital health companies across Europe.

Discover more: www.mia-care.io

Docs: docs.mia-care.io