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.
