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 ...

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 ...

Successful risk management is essential to the design and development of safe and effective medical devices. Unfortunately, it is too often viewed by manufacturers as an isolated activity that must be ...

The "An introduction to Risk Management ISO 14971:2019 Training Course (Apr 27, 2026)" has been added to ResearchAndMarkets.com's offering. Understand the use of risk management in the medical device ...

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) ...

Add Yahoo as a preferred source to see more of our stories on Google. A new survey by cybersecurity company Asimily has identified that persistent visibility gaps and internal process breakdowns are ...

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 ...