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 ...

Filing medical device reports (MDRs) is undesirable and presents a certain amount of risk to the manufacturer. Fortunately, this risk can be ameliorated by approaching event reporting mindfully and ...

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 ...

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 ...

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) ...

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 ...

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 ...

Medical software is the backbone of modern healthcare, supporting electronic health records (EHRs), diagnostic systems, imaging technologies and embedded software in medical devices like pacemakers ...

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 ...