ISO 13485 Consultants for the Medical Device Industry

Whether you need assistance with ISO 13485 implementation, pre-certification/supplier audits or on-site employee training, our experienced ISO 13485 consulting team is ready to make sure you obtain and maintain ISO 13485 certification with the least amount of disruption to your business. We work with a wide range of medical device manufacturers, from smaller companies introducing a product to the European or Canadian markets, to larger companies needing assistance with ISO audits and training. We are able to offer ISO 13485 consulting expertise to companies located in North America, Europe and Asia. In addition to our quality management system consulting services, we offer a wide range of global medical device regulatory RA consulting services.

ISO 13485 CONSULTING – ISO implementation at your facility Helping companies implement ISO 13485 is a core specialty. We can fully assist with achieving ISO 13485 certification, integrating ISO 13485 with your existing US FDA QSR quality system, or upgrading from ISO 9001.
ISO 13485 AUDITING – Assistance with internal and supplier audits Emergo Group has ISO 13485 auditors located in key locations throughout the USA, Canada, Europe and Japan. Our experienced team can assist with ISO 13485 (and QSR) internal or supplier audits as your needs dictate.
ISO 13485 TRAINING – On-site, custom training for employees Our on-site ISO 13485 training is an excellent value if you need to train three or more people on ISO 13485. We can also combine this with training on European, US, Canadian or Japanese regulations. We can fully customize training to your needs!
TIME – How long it takes to achieve ISO 13485:2003 certification Learn more about what internal resources will be needed at your company and how long it will take for your company to successfully achieve ISO 13485:2003 certification.