AI in MedTech Regulatory
FDA, EU AI Act, PCCP and ISO/IEC 42001 alignment for AI/ML SaMD.
Digital Health & AI
SaMD, AI/ML, clinical decision support, digital therapeutics.
How we serve Digital Health & AI.
Digital health products and AI tools are regulated when software impacts diagnosis, treatment monitoring or clinical decisions. We back Software as Medical Device (SaMD), devices enabled by AI/ML, clinical decision support, digital markers for health, remote monitoring, platforms that are sensitive to cybersecurity and software tools that diagnose.
We assist teams in aligning claims for products, intended use, risk classification, clinical validation, documentation for software lifecycle, PCCP strategy for cybersecurity, usability, quality systems and handling post market changes. The aim is straightforward: make innovation defensible before reviewers ask hard questions.
FDA SaMD Guidance
FDA AI/ML and PCCP expectations
FDA Cybersecurity Guidance
EU MDR 2017/745
EU AI Act
IEC 62304
IEC 62366-1
ISO 14971:2019
ISO/IEC 42001
ISO 27001
IMDRF SaMD Framework
Where we typically engage with Digital Health & AI clients.
Service detail
FDA 510(k) Clearance
Substantial equivalence strategy for software-enabled medical devices.
FDA De Novo Classification
Risk-based pathway for first-of-kind digital health and AI technologies.
EU MDR Compliance
EU MDR classification, clinical evaluation and software technical documentation.