For decades, risk management in the medical device and in vitro diagnostic (IVD) sectors has suffered from an identity crisis. The industry has universally recognized the ISO 14971 standard as the ...

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 ...

Two important standards define the quality systems used in the medical device industry: ISO 13485:2003 and ISO 14971:2000 (up for revision in 2007). These standards specify the important requirements ...

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 ...

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 ...

Weak authentication for medical devices (or a lack of it) has become a sweet spot for cyber criminals. Hackers accessed 1.2 million medical devices and exposed sensitive and protected information ...

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 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 ...

For medical device manufacturers targeting the European Union market, compliance with the Medical Device Regulation (MDR) is ...

Nine requirements management tools for medical device development ranked by traceability, compliance support, and regulatory readiness for FDA and EU MDR.