Medical device regulatory experts with Notified Body experience providing proven, cost-effective solutions for EU MDR, FDA QMSR and ISO 13485 compliance.
Our team combines decades of experience working with top Notified Bodies and leading medical device companies. This unique perspective allows us to deliver:
Solutions tailored to your specific device classification and regulatory pathway
Process optimizations that reduce compliance costs while improving quality
Systems designed to withstand Notified Body and FDA scrutiny
We support the entire product lifecycle with specialized expertise in:
Schedule a free consultation with our Medical Device Regulatory Experts today.
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:
With experience across all device classes and therapeutic areas, we customize our approach to your specific regulatory challenges. Learn more about our team.
