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 ...

All medical devices have risk. “You, as the manufacturer, are responsible for determining the risk of your medical device and if that risk is acceptable,” said Joseph Tartal, FDA deputy director in ...

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 ...

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 ...

Structural flaws are hiding in plain sight, and a shift is long overdue, writes Pujitha Gourabathini at Becton, Dickinson 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 ...

The International Medical Device Regulators Forum (IMDRF) has released a draft technical document to create a harmonized set ...

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, ...

The data reveals key market opportunities in enhancing compliance through expertise in PMS, PMCF, and vigilance for digital health technologies. Emphasizing real-world data, risk management, 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 ...