Case Study - Lessons from an FDA warning letter

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Deep-dive case studies for paid subscribers

Paid subscribers have free access to deep-dive case studies, either in a live webinar presentation or in a full-length premium article.

Recently, we talked about a warning letter to a manufacturer of a modular cooler-heater (MCH) that is used to control a patient’s temperature during cardiopulmonary bypass procedures.

In this case study, we review some of the FDA observations in the warning letter that highlight potential gaps in the risk management process and share some practical tips for you to consider.