ISO Medical Device Standards

ISO 13485 and ISO 14971, sometimes referred to as ISO medical device standards, are two of the most relevant and widely recognized standards for producing med devices. Adhering to these standards is voluntary, but even countries that enforce obligatory regulations – such as those set forth by the U.S. FDA – encourage and expect med device manufacturers to follow them as a matter of good manufacturing and business practice.

ISO 13485 - Change? Do I Have To??