Section 8.4 of ISO 13485:2016 emphasizes a systematic approach to collecting and analyzing data to optimize QMS, ensure the safety and effectiveness of medical devices, and continuously improve the organization’s performance in the medical device industry.

Analysis of data is integral to maintaining regulatory compliance and achieving customer satisfaction. The organizations need to gather and analyse data from various sources, including:

1. Feedback – Customer feedback, including complaints and post-market surveillance.
2. Conformity to product requirements – Information from the occurrence of nonconforming products or processes. Data was collected during routine quality control activities, production processes, and performance monitoring.
3. Characteristics and trends of processes and products _ Data collected during routine quality control activities, production processes, and performance monitoring.
4. Suppliers – Data on the quality and reliability of materials and components sourced from suppliers.
5. Audits – Findings from internal and external audits can reveal areas for improvement in your QMS.
6. Service reports – service reports and user satisfaction surveys provide valuable insights into device performance