Regulatory Expertise That Accelerates Innovation
Fast-track your medical device compliance with smart, agile strategies. EU MDR, FDA, AI Act—global certification doesn't need to be long and difficult.
Smart Strategies, Fast Results
From MDR to FDA, ISO 13485 certification to AI Act compliance — comprehensive regulatory support that accelerates your market entry.
EU MDR Compliance
Navigate European Medical Device Regulation with confidence and speed.
- Technical Documentation
- Clinical Evaluation
- Post-Market Surveillance
FDA Submissions
Streamlined pathway to US market approval with proven success rates.
- 510(k) Clearance
- De Novo Classification
- PMA Applications
ISO 13485 Certification
Quality management systems that meet global regulatory standards.
- Gap Analysis
- Documentation Support
- Audit Preparation
AI Act Preparation
Stay ahead of emerging AI/ML medical software regulations.
- Risk Classification
- Compliance Roadmap
- Documentation Strategy
SaMD Strategy
Software as Medical Device expertise for digital health innovators.
- Classification Support
- Clinical Evidence
- Regulatory Pathway
Global Registration
Multi-market entry strategies for international expansion.
- Market Analysis
- Regulatory Intelligence
- Local Partner Network
Trusted by Industry Leaders
"The AI Act compliance strategy developed by Marta provides our clients with a clear, actionable pathway for advancing their ML-based diagnostic tool. Her exceptional regulatory insight and strategic approach make her an invaluable external expert to our team."
Authority You Can Trust
Combining academic knowledge with practical experience to deliver regulatory solutions that work in the real world.
Academic Excellence
Lecturer in digital health and regulatory compliance, teaching courses on AI-related compliance challenges and medical device conformity assessment in Europe.
Global Experience
Over a decade navigating EU MDR, FDA, TGA, and emerging AI Act regulations across 10+ countries.
Person Responsible for Regulatory Compliance (PRRC)
ensuring end-to-end conformity with MDR and global regulatory frameworks while driving high-quality, compliant innovation across the organization.
Certified Expert
Certified Quality Excellence specialist, trained ISO 9001 Lead Auditor, and qualified Internal Auditor for ISO 13485, with practical experience supporting QMS for medical and AI-based software.
QMS Leadership
Designated management representative for the ISO 13485 quality management system, responsible for oversight of compliance, performance, and continuous improvement across the organization.
Trusted Network
Established partnerships with Notified Bodies and accredited testing laboratories, supported by a global network of regulatory consultants, legal experts, and industry organizations.
For Your Successful Certifications
Serves as the Person Responsible for Regulatory Compliance, ensuring end-to-end conformity with MDR and global regulatory frameworks while driving high-quality, compliant innovation across the organization.
Ready to Accelerate Your Regulatory Journey?
Book a free consultation to discuss your compliance needs. Whether you're navigating EU MDR, FDA submissions, or AI Act preparation—let's create a fast-track strategy together.
- Free 30-minute strategy session
- Personalized compliance roadmap
- Timeline and cost estimates
- No obligation, just expert guidance