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.

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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

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Let’s Discuss Your Regulatory Needs

Schedule a free consultation with our Medical Device Regulatory Experts today.

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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.

 

Quality Management System
ISO Statutory
MDD (European Union)
USA FDA
ANVISA (brasil)
PMDA (Japan)
MDALL (Canada)
TGA (Australia)
TGA (Australia)