We are on the verge to merge. Things in the regulatory space for medical device manufacturers are about to get easier.
In a new proposal on Quality System Regulation Amendments for Medical Devices, The FDA has decided to harmonize their GMP requirement for medical devices by incorporating the QMS requirements from ISO 13485.
This harmonization will ease the regulatory burden on medical device manufacturers selling on both sides of the Atlantic. Medical Device Manufacturers and their suppliers and subcontractors that are ISO 13485 certified will no longer have to comply with a different set of standards for approval in the USA.
SAXOCON is ISO 13485 certified and can help you with your QMS, which helps you comply with all relevant regulations but also gives you a better understanding of your supply chain and manufacturing processes.