Medical Device Cleanroom Classification
What Kind of Cleanroom Do I Need for a Class II Medical Device? What About Class III? This post classifies medical device cleanrooms for manufacturing and packaging.
ISO 13485
ISO 13485:2016 Medical Devices
ISO 13485 is designed for use throughout the life cycle of a medical device. It supports each stage of medical device development and operation from initial concept to production and disposal. The standard helps internal and external parties certify and validate processes which maintain the stability of quality management systems (QMS).
