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.