ISO 13485 Audit Requirements and Checklist

ISO 13485:2016 is one of the most popular international standards that apply to medical device manufacturers and suppliers. Although using the standard is voluntary, the U.S. Food and Drug Administration (FDA) and its counterparts in Canada, Australia, Japan, and the European Union, encourage and expect medical device firms to adhere to the standards. ISO 13485 was updated in 2016 to address technological advances and regulatory changes. The standard covers quality management system essentials, as well as ISO 13485 audit requirements.

Understanding ISO 13485: 2016 — A Brief, Yet Comprehensive, Overview