FDA QSR Quality Management System Consulting
The US Food and Drug Administration (FDA) regulates the design, manufacturing, packaging, labeling, storage and delivery of medical devices. The laws requires "manufacturers" to implement a quality system that meets the FDA Quality System Regulation found in 21 CFR Part 820. The QSR is also commonly referred to as current Good Manufacturing Practice (cGMP).
Who needs to meet the FDA Quality System Regulations (QSR)?
In general, if your company manufactures a medical device, you will be required to implement a FDA compliant quality management system. Emergo Group can help you implement a quality system that meets the QSR (also known as current Good Manufacturing Practice - cGMP) or modify your existing quality system to meet the FDA requirements. We have implemented quality management systems for hundreds of medical device companies.
Meet the requirements of Europe, Canada, Japan and Australia.
Emergo Group can modify your quality system to accommodate the all of the requirements for Europe, Australia, Japan, and Canada. Even if you have no immediate plans to sell in these markets, you will be well positioned for expansion in the future. If you already have ISO 13485 certification, we will ensure that our FDA QSR consultants modify your system in a way that seamlessly integrates all requirements into one system.
Contact us for more information on FDA QSR (Quality System Regulations) consulting support and implementation.
