ISO 13485:2016 provides an international standard that can be truly harmonized across multiple regions and regulatory requirements. But it also introduces notable QMS changes, particularly in the area of risk management. In this 16-page white paper, we answer your biggest questions about ISO 13485:2016, including:

Overview of the update to the new standard

Breakdown of what has changed in each section

Guidelines on how to prepare for the new standard

Deadline for recertification

Requirements for recertification

Considerations for timing the update and recertfication

Learn all this and more in this white paper.