Why Aenomed Advisory ?
Expert Guidance, From Strategy to Compliance
Aenomed Advisory was founded to bridge the gap between innovative medical technology and the regulatory frameworks required to bring it safely to market. We combine deep technical expertise with a practical, client-first approach across all global regulatory environments.
Global Multi-Region Coverage
We support regulatory processes across the EU, UK, USA, and international markets with region-specific expertise.
Specialized in SaMD & Digital Health
One of our key differentiators is deep expertise in Software as a Medical Device — a fast-evolving and complex regulatory field.
Hands-On Partnership Model
We work as an extension of your team — not just as advisors — with dedicated support at every milestone.
End-to-End
Full product lifecycle support — from concept to post-market
ISO 13485 Aligned Operations
Quality-first approach embedded in everything we deliver
Multi-Market Regulatory Reach
EU · UK · USA · Global — one partner for all regions
SaMD & Digital Health Specialists
IEC 62304 · IEC 82304-1 · FDA SaMD frameworks
SaMD Expertise
Navigating Software as a Medical Device Regulation
Software as a Medical Device is one of the most rapidly evolving and uniquely complex areas of medical device regulation. Aenomed Advisory brings specialized knowledge in SaMD classification, documentation, and lifecycle management across all major regulatory jurisdictions.
Whether you are building AI-driven diagnostics, clinical decision support tools, or connected health platforms, our team ensures your software documentation, risk management, and submissions are fully aligned with current and emerging requirements.
IEC 62304
SW Lifecycle Processes
IEC 82304-1
Health Software Safety
FDA SaMD Guidance
US Market Requirements
EU MDR / IVDR
European Compliance
Cybersecurity
MDCG & FDA Guidance
V&V Support
Verification & Validation