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 ...

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 ...

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 ...

Jochen Schwenk is CEO of Crisis Control Solutions LLC & Schwenk AG, an expert in risk and crisis management for the automotive industry. Risk management is a critical component of daily life and, of ...