Category: Certifications

ISO 13485: Frequently Asked Questions Answered

Doctor Discussing Health Information

Recent news that the US Food and Drug Administration (FDA) will use ISO 13485 as the basis for its quality system legislation for medical devices was well received by those in the industry, perhaps none more than the ISO (International Organization for Standardization) itself. ISO 13485 is the international standard for quality management systems (QMS)… Read more »