[ISO 13485 Cl 8.2.1] 

Clause 8.2.1 of ISO 13485 emphasizes the importance of systematic collection, analysis, and action on the feedback to maintain and improve the quality and safety of medical devices. This feedback helps to assess the ongoing effectiveness of the quality management system and identify opportunities for improvement in your devices throughout their lifecycle. This proactive approach ensures that organizations can effectively respond to user needs and regulatory requirements.

The feedback can be collected from various sources throughout the product lifecycle, including:

• Post-production activities: Customer complaints, service reports, field observations.
• Post-market surveillance: Data on device performance, adverse events, and user experiences are collected after the device is available in the market.

The organization should communicate with customers and regulatory authorities regarding feedback and any resulting actions.