iso 13485

In this recent Application Note, SCHURTER emphasizes the importance of compliance with the medical standard DIN EN ISO 13485 to ensure the safety and reliability of medical equipment, specifically as it relates to the development and integration of HMI solutions.

The U.S. Food and Drug Administration (FDA) has amended its quality system regulations applicable to the manufacture of medical devices.

The U.S. Food and Drug Administration (FDA) has requested public comment on its plan...

Medical device veteran Jon Speer breaks down the latest changes in the medical device regulatory landscape, both in Europe and the U.S.

New Handbook Helps Medical Devices Sector Improve its Quality Management System

After nearly four years of work, the International Organization for Standardization (ISO) has published...