Customer Service:
Mon - Fri: 8:30 am - 6 pm EST

 Most recent

ISO 9001 / ISO 13485 - Quality Management for Medical Devices Set

ISO 9001 and ISO 13485 Medical and Quality Management Set

ISO 9001 / ISO 13485 - Quality Management for Medical Devices Set provides the regulatory reguirements for your medical devices quality management system. ISO 9001 / ISO 13485 - Quality Management for Medical Devices Set enables an organization to consistently meet customer and regulatory expectations as it pertains to the quality management of medical devices. The ISO 9001 / ISO 13485 - Quality Management for Medical Devices Set is applicable to all medical devices organizations and it includes:

ISO 9001:2015
ISO 13485:2016
ISO 9001:2015 for Small Enterprises - What to do - (Value Added Content)

ISO 9001 / ISO 13485 - Quality Management for Medical Devices Set includes:

Content Provider
International Organization for Standardization [ISO]


ANSI Logo

As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.

CUSTOMER SERVICE
NEW YORK OFFICE
ANSI HEADQUARTERS