Medical Device Regulatory Experts You Can Trust
Medical device regulatory experts with Notified Body experience providing proven, cost-effective solutions for EU MDR, FDA QMSR and ISO 13485 compliance.
Contact Us TODAY
Why Choose MDR Consultants?
Our team combines decades of experience working with top Notified Bodies and leading medical device companies. This unique perspective allows us to deliver:
Regulatory Precision
Solutions tailored to your specific device classification and regulatory pathway
Cost Efficiency
Process optimizations that reduce compliance costs while improving quality
Audit-Ready Results
Systems designed to withstand Notified Body and FDA scrutiny
Comprehensive Medical Device Services
We support the entire product lifecycle with specialized expertise in:
- ✓ Training & Education Programs
- ✓ QMS Transition (EU MDR/MDSAP/UKMDR)
- ✓ ISO 13485:2016 Implementation
- ✓ Risk Management (ISO 14971:2019)
- ✓ Compliance Gap Analysis
- ✓ Product Design & Development
- ✓ Quality System Procedure Development
- ✓ Premarket Submissions (510(k), PMA)
- ✓ Technical Documentation Management
- ✓ Clinical Evaluation Reports
- ✓ Post-Market Surveillance
- ✓ Vigilance Reporting
- ✓ Remediation Projects
- ✓ FDA 483 Response Support
View All Services →
Let’s Discuss Your Regulatory Needs
Schedule a free consultation with our Medical Device Regulatory Experts today.
Book Now
Trusted Medical Device Regulatory Consultants
MDR Consultants provides comprehensive medical device regulatory consulting services to help manufacturers navigate complex global requirements. Our team of former Notified Body lead auditors and FDA inspection veterans offers practical, implementation-focused guidance for:
- EU MDR compliance
- FDA QMSR transition
- ISO 13485 certification
- Risk management systems
- Technical documentation
- Audit preparation
With experience across all device classes and therapeutic areas, we customize our approach to your specific regulatory challenges. Learn more about our team.