Complaint Handling in Compliance with FDA and ISO Regulations

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 discuss the best way to document customer feedback, what constitutes a complaint, and what do with "non-complaint" feedback. Also contained will be a suggested method on including complaint trending into your firm's CAPA program. Additionally, the application of risk management to a complaint handling system will be reviewed, and a specific risk management system explained.

Areas Covered in the Session:

• FDA and ISO requirements for complaint handling
• Establishment of complaint handling program
• What constitutes a complaint
• ISO-specific implications of complaint handling
• The roles of investigation and corrective action in complaint handling
• Complaint trending and reporting
• Application of risk management to complaint handling program

• Regulatory Management
• QA Management
• Customer Service Personnel
• Sales Personnel
• Consultants
• Quality System Auditors