The new ISO 13485:2016 encompass high impact changes for the industry of medical devices. The new standard will demand new ways of interaction with suppliers, required mainly by the “risk based approach”.
In this article, Walt Murray discusses the importance of the “risk based approach” for the correct performance and adequate safety of medical devices. He also clarifies the changes of the new 13485:2016 standard, and how this impacts the relationship between medical device makers and suppliers.
Langage: Anglais
Auteur
Walt Murray