FDA cGMP Consulting for Medical Device Quality System Compliance

The US FDA regulates the design, manufacturing, packaging, labeling, storage and delivery of medical devices. The laws requires "manufacturers" to implement a quality system that meets Quality System Regulation found in 21 CFR Part 820. The QSR is also commonly referred to as current Good Manufacturing Practice (cGMP).

Which companies need to implement FDA cGMP?

In general, if your company manufactures a medical device, you will be required to implement a quality management system that is FDA cGMP compliant. The FDA considers you a "manufacturer" even if you completely outsource all of your manufacturing activities and therefore most companies that market a Class II or higher device must implement cGMP. Emergo Group can help you create a quality system that meets cGMP or modify your existing ISO 13485 quality system to meet cGMP requirements. We have implemented quality management systems for hundreds of medical device companies making a wide variety of medical devices and performing numerous manufacturing processes.

Meet the requirements of Europe, Canada, Japan and Australia.

As mentioned above, Emergo Group's cGMP consultants can modify your quality system to accommodate all 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 maintain ISO 13485 certification, we will ensure that our FDA cGMP consulting team modifies your system in a way that seamlessly integrates all requirements into one system.

Contact us for more information on FDA cGMP consulting support and implementation.