Global Medical Device & SaMD Advisory
Regulatory Confidence
for Innovative Medical
Technologies
KNOW MORE
Global Medical Device & SaMD Advisory
Regulatory
Confidence for
Innovative
Medical Technologies
Aenomed Advisory partners with medical device and Software as a Medical Device manufacturers to navigate complex global regulatory landscapes — from initial strategy through market access and beyond.
GLobal
Multi-region reach
End-to-End
Full lifecycle support
Core Competencies
Regulatory Strategy & Compliance
CE Marking · FDA · MDR · IVDR
SaMD Lifecycle Support
IEC 62304 · IEC 82304-1 · FDA SaMD
Quality Management Systems
ISO 13485 · ISO 14971 · MDSAP
Post-Market & Vigilance
Post-Market & Vigilance PMS · CAPA · Complaint Handling
STANDARDS & FRAMWORKS
What We Do ?
Comprehensive Services Across the Full Product Lifecycle
Every service we offer is built around your product’s unique regulatory journey — from first concept to global market presence.
Regulatory Strategy & Compliance
We develop and implement tailored regulatory strategies that align with your product type, target markets, and business timelines.
- CE marking and EU MDR/IVDR compliance
- FDA submission strategy and support
- Regulatory gap assessments
- Technical documentation preparation
Quality Management
Systems
We design, implement, and maintain robust QMS frameworks that satisfy global regulators and auditors at every stage.
- ISO 13485, ISO 14971 & IEC 62304 aligned QMS
- Internal, supplier & QMS health-check audits
- QMS digitalization advisory
- Certification audit readiness support
Risk Management & Clinical Evaluation
We build and maintain risk management files and clinical evaluation packages that meet current regulatory expectations worldwide.
- Risk management files per ISO 14971
- Clinical evaluation & PMS documentation
- Benefit-risk analysis & reporting
- Compliance with current regulatory guidance
SaMD Lifecycle & Technical Documentation
Specialized support for Software as a Medical Device throughout classification, development, and validation phases.
- SaMD classification & development planning
- Software architecture & requirements traceability
- Cybersecurity & usability documentation
- Verification & validation (V&V) support
Regulatory Submission & Communication
We prepare, compile, and manage your regulatory submissions while acting as your expert liaison with authorities and notified bodies.
- 510(k), Technical File & Design Dossier preparation
- Liaison with regulatory authorities
- Notified body communication & audit support
- Query response management
Post-Market & Vigilance Support
We establish and manage the post-market frameworks that keep your product compliant and your organization protected after launch.
- PMS plan & report development
- Vigilance & complaint-handling processes
- CAPA management & continuous improvement
- Field safety corrective action support
Ready to Accelerate Your Path to Market?
Let Aenomed Advisory provide the regulatory clarity and expert support your medical technology deserves.
How We Work ?
A Structured Path to Regulatory Success
Our methodology is built on clarity, precision, and client collaboration — so you always know exactly where you stand.
Discovery & Assessment
We evaluate your product, intended markets, and current regulatory posture to identify gaps and opportunities.
Strategy & Roadmap
A customized regulatory and quality roadmap is developed with clear milestones, deliverables, and timelines.
Documentation & Submission
We prepare all required technical files, quality records, and regulatory submissions to the highest standard.
Post-Market & Continuous Support
We manage your ongoing compliance, vigilance reporting, and regulatory monitoring after market access is achieved.