iso 13485

SCHURTER Elevates Medical Device Standards with ISO 13485 Compliance

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.

FDA Amends Quality System Regulations for Medical Devices

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

FDA to Amend Medical Device Quality System Regulation

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

A Tsunami of Regulatory Changes is Coming

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

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ISO Publishes Revised Medical Device Quality Management Standard

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

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iso 13485

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What's New

FDA Struggles to Meet Product Review Deadlines

Design and Operation of Antennas

FDA Warns Against Unauthorized Modifications to Medical Devices

ESD Testing Parameters

FDA Alerts the Medical Device Industry About Unreliable Third-Party Test Data