Posts tagged Class I Recall

Risk Management Lessons from a Class I Recall

A class I recall of a pediatric device used to provide life-critical breathing support offers important lessons for Risk Management

Risk ManagementNaveen AgarwalFebruary 10, 2020Class I Recall, Pediatric Device Recall, Babi.Plus Pressure Relief Manifold, Babi.Plus Pressure Relief Manifold recall, quality management system, QMS, Bubble CPAP system, medical device recall, medical product recallComment

Can Your Risk Management Prevent a Recall?

Even if you have not had a recall, or your products are not in the top medical specialties cited in this article, there is a good chance your Quality Management System (QMS) is also vulnerable to deficiencies in these areas.

Risk ManagementNaveen AgarwalJune 12, 2019FDA regulation, safety, medical safety, patient safety, Class I Recall, Medical Device RecallsComment