Navigate Medical Software Compliance with Confidence
From MDR and MDCG to GDPR and AI-Act compliance – we guide medical device manufacturers through complex regulatory landscapes, ensuring your software meets all EU requirements.
Why Choose Zell Medical Consulting?
We combine deep regulatory expertise with practical implementation experience to ensure your medical software not only meets compliance requirements but thrives in the market.
Regulatory Expertise
Deep understanding of MDR, IVDR, and evolving EU regulations
Proven Track Record
Successfully guided 50+ medical software products to market
End-to-End Support
From initial assessment to final CE marking and beyond
Risk-Based Approach
Tailored strategies that match your product's risk profile
Our Expertise
Comprehensive Compliance Solutions
Regulatory Affairs & Compliance
Navigate MDR 2017/745 and IVDR 2017/746 with confidence. We provide complete regulatory strategy, technical documentation, clinical evaluation, and post-market surveillance planning.
Data Protection & GDPR
Ensure your medical software protects patient data according to GDPR requirements. From privacy-by-design to data processing agreements, we cover all aspects of healthcare data protection.
AI in Medicine & AI-Act
Stay ahead of AI regulation in healthcare. We help you prepare for the EU AI Act, ensuring your AI-powered medical devices meet both MDR and emerging AI-specific requirements.
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Your Path to Compliance
Initial Assessment
We analyze your medical software, identify applicable regulations, and create a tailored compliance roadmap.
Documentation & Implementation
Develop technical files, clinical evaluations, and implement quality management systems to MDR standards.
Certification Support
Guide you through notified body interactions, audits, and ensure successful CE marking achievement.
Ongoing Compliance
Maintain compliance with post-market surveillance, vigilance reporting, and regulatory updates.
Client Success Stories
Trusted by Medical Device Innovators
“Zell Medical Consulting guided us through the entire MDR compliance process. Their expertise saved us months of work and ensured our AI-powered diagnostic tool achieved CE marking on schedule.”
“The team's deep understanding of both GDPR and medical device regulations was invaluable. They helped us implement privacy-by-design principles without compromising functionality.”
Ready to Ensure Your Medical Software Compliance?
Get a free initial consultation and compliance assessment for your medical device software.
No obligation • 30-minute call • Expert guidance
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Have questions about medical device compliance? We're here to help.