dical Device Consulting Services

Gain the benefits of receiving medical device consulting services from former Notified Body auditors ensuring compliance with EU MDR, FDA QMSR, and ISO 13485 requirements.

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From Concept to Market

End-to-end guidance for medical device development and regulatory approval

Compliance Assurance

QMS implementation that meets global regulatory requirements

Audit Readiness

Preparation for Notified Body and FDA inspections

Comprehensive Medical Device Consulting

Our medical device consulting services ensure your Quality Management Systems meet all regulatory requirements while maintaining product safety. We implement solutions that achieve both compliance and business objectives.

Whether bringing a new device from concept to market or maintaining existing products, we guide companies through:

  • Design and development processes compliant with ISO 13485
  • Regulatory strategy for EU MDR, FDA QMSR, and global markets
  • Technical documentation and submission preparation
  • Post-market surveillance and vigilance requirements

Why Choose Our Consulting Services?

With decades of experience across all device classes, our former Notified Body auditors provide practical, implementation-focused guidance tailored to your specific regulatory challenges.

Ready to Accelerate Your Regulatory Success?

Schedule a free consultation with our lead consultants today.

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Expert Medical Device Consulting

MDR Consultants provides industry-leading medical device consulting to help manufacturers navigate complex global regulations. Our team of former Notified Body auditors and FDA inspection veterans offers specialized expertise in:

  • EU MDR compliance strategy
  • FDA QMSR transition
  • ISO 13485 implementation
  • Risk management systems
  • Technical documentation
  • Audit preparation

With experience across all device classes and therapeutic areas, we customize our approach to your specific product development and regulatory needs.

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