The ISO 14971 regulation lays out an entire risk management framework for medical devices. Regardless of what country you are manufacturing your devices in, they all view this ISO guideline as acceptable for risk management processes. There are many topics covered in this document, but overall I believe it is useful for identifying your hazards/ricks, evaluating these risks, and developing monitoring systems for risk controls. It’s important for your company to have a risk management framework, so that you are prepared to deal with anything that comes your way. This includes an entire process for risk management, establishing roles and responsibilities so everyone knows what they are in charge of, documentation of plans and establishing risk managing files that are continually changing.

Kaitlin Connell