ALARP to AFAP, the MDR and ISO 14971:2019+A11:2021

The risk management approach ALARP (As Low As Reasonably Practicable) to AFAP (As Far As Possible) and medical device risk management has always been a tricky one. The nature of the products, their intended use, and the markets in which they are sold influences the approaches in controlling risk. When it comes to risk, the […]