Search the internet and you will find many consultants who can implement and audit quality management systems. However, finding a consultant that understands how to create a single quality system that meets the regulatory requirements of Europe, Canada, Japan, the US and other countries is challenging. Emergo Group understands the regulations in all these markets and works with every client to create and maintain a single harmonized quality system that blends ISO 13485 and US FDA Good Manufacturing Practice (GMP) together while meeting unique national requirements. Whether you need assistance with ISO 13485 implementation, pre-certification/supplier compliance audits or on-site training, our experienced ISO 13485 consulting team is ready to make sure you obtain and maintain compliance with the least amount of disruption to your business. In addition to our ISO 13485:2003 consulting services, we offer a wide range of medical device QA and RA consulting services related to the US, Canada, Mexico, China, Japan, Europe, Russia and Australia.
ISO 13485 Consultants for the Medical Device & IVD Industry