Manufacturer’s of medical devices are often faced with meeting multiple standards or regulations for regulatory compliance.
However, existing training products often fall short and only address FDA Quality System Regulation requirements or
ISO 13485 requirements.
QARACC’s “QMS Requirements Training” module was designed to meet both needs by offering
organizations a training program for employees that addresses both FDA QSR and ISO 13485 quality management system
requirements.
The QMS Requirements Training module was designed to provide employees with a basic understanding of the quality
management system requirements that pertain to the design, manufacture and distribution of medical devices. It is ideal
for employee orientation or annual refresher training as it provides employees with an overview of the requirements in clear,
easy to understand language.