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 ...

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 ...

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, ...

Asimily’s report reflects that a significant number of US hospitals struggle with sufficient visibility process management of ...

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 ...