Medical Device 2012 - Complaint Handling in Compliance with FDA and ISO Regulations

This training will show how you can handle customer complaints in compliance with FDA and ISO Regulations. We will discuss the best ways to document customer feedback, what constitutes a complaint, what do with "non-complaint" feedback, and how to include complaint trending into your firm’s CAPA program.

Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control. This feedback is therefore subject to many requirements in both the QSR and ISO 13485. Failure to follow up on complaints about medical devices is among the most frequently cited observations on FDA-483s. This session will include the requirements for defining, documenting, and implementing a complaint-handling system, including the requirements for complaint review, investigation, and corrective action, as well as the ISO-specific implications.