IMDRF

MDSAP Extends Remote Auditing Option

The International Medical Device Regulators Forum (IMDRF) has temporarily extended the limited use of...

IMDRF Issues Draft Guidances for Medical Devices

The International Medical Device Regulators Forum has recently issued drafts of two separate guidance documents that may be of interest to medical device manufacturers.

TÜV SÜD America Authorized to Audit Within the MDSAP Pilot Program

TÜV SÜD America is one of the first auditing organizations (certification bodies) to become...

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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

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