Harvey Rudolph Underwriters Laboratories Inc. A popular catchphrase these days is risk management. It is being used by regulators worldwide, as well as by standards developers and others whose ...

The FDA released their updated guidance on Cybersecurity in medical devices: Quality System Considerations and content for Premarket submissions at the end of June in 2025. In this guidance the FDA ...

Safety risk management of medical devices is governed by the international standard: ISO 14971. Besides understanding the formal requirements of ISO 14971, successful risk management requires the ...

The healthcare industry faces an unprecedented cybersecurity crisis as connected medical devices proliferate at an alarming ...

ISO 14971 provides a framework for medical device manufacturers to identify and minimize risks through the design and manufacturing processes. Adhering to the standard helps ensure overall safety and ...

These definitions as written out by AAMI (The Association for the Advancement of Medical Instrumentation) offer clarity, helping designers recognize and address these risks effectively in product ...

In today’s highly connected world of healthcare, medical devices have become fully integrated elements of patient care and treatment. But a high scale of deployment also brings greater exposure to ...

All device professionals know they have to perform risk management. And to do it, many firms rely on the widely accepted standard for product risk management: Failure Modes and Effects Analysis (FMEA) ...

What often appears to be turf wars between healthcare technology management, facilities OT staff, IT departments and security ...

Trust is one of the greatest investments anyone could make in healthcare. Patients who put their lives in the hands of healthcare institutions and personnel do so with an unmitigated amount of trust, ...

Language Scientific has provided a practical overview of IFU translation requirements for medical device documentation, emphasizing how clear and accurate Instructions for Use support patient safety, ...