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 ...

Once the risk team has been assembled, the crucial process of identifying risks must commence. The output of the risk ...

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 ...

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 ...

IEC 60601 is no longer a standard of absolutes. The third edition allows, and in some instances requires, safety features and test requirements to be modified on the basis of risk management. By ...

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, ...