[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.

The Key Requirements

1. Establish a Feedback System that must be capable of collecting and analyzing product-related feedback from the field. Applies to all lifecycle stages, including design, production, post-market use

2. Use Feedback collected as Input for Product improvement, Complaint investigations (linked to Clause 8.2.2), CAPA system (Clause 8.5.2 and 8.5.3), Regulatory reporting (Clause 8.2.3), Management review (Clause 5.6)

3. Feedback received from Customer surveys, Product returns data, Field service reports, Customer complaints, Social media or app-based reviews, Distributors, sales reps, or maintenance engineers