Expert Consultants in Quality Management Systems

 

MDR Consultants strives to provide you with proven, trusted, and cost-effective solutions. We specialize in the generation, auditing, and remediation of medical device Quality Management Systems.

 

The goal of establishing, implementing, and maintaining a Quality Management System is to provide a system of control over processes so that products can continually meet pre-determined requirements.

 

Our consultants have years of experience working for Notified Bodies and leading medical device companies that implement these practices; this knowledge allow us to offer you solutions tailored specifically to your needs while ensuring compliance and conformance with applicable standards and regulations and at the same time, increasing efficiency and effectiveness of your organization that will certainly reduce your costs. We have the expertise you need for the success of your medical device products.

 

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