Medical device companies MUST have established risk management processes that comply with ISO 14971. And it doesn’t matter if you are developing medical devices in the U.S., EU, Canada, and so on. ISO ...

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 ...

The IEC 60601 standards series is one part of putting together a technical file or a 510(k) submission. It’s about more than electrical safety — it covers mechanical safety, labeling and risk ...

The third edition of IEC 60601-1 is filled with new and revised requirements. Particularly, manufacturers who had been operating using the second edition of the standard will find the most significant ...

Risk management is the process of identifying potential risks and/or harms and creating a plan to prevent the risk from happening or reduce the risk as much as possible. There are different types of ...

Health care in the United States is stretched to its limit, and those who enter the medical field want to be able to provide the best care possible for their patients. For nurses, usually the backbone ...

As a business owner, it is essential to understand the risks associated with your operations and how to manage them effectively. Risk management is necessary for long-term business success and ...

Today, virtually every business depends to some degree on third parties for supporting products and services. In some cases, these third parties supply something simple, such as office supplies, ...

The Risk Management Employment Claims Initiative is an education program that supports employees and supervisors in understanding employment-related issues. This program consists of four modules ...

There’s an unfortunate stereotype that risk management is boring. Risk managers are pessimistic clerks. Compliance officers are scaremongers. Too many managers think this way. As a result, risk ...

Risk management helps us think ahead to identify and address potential threats and seize opportunities to ensure the smooth delivery of our programmes. By managing risks proactively, we prevent ...