Aligning Supplier Evaluation Practices with 21 CFR 820 and ISO 13485 Requirements

Supplier assessment is significant for ensuring product quality, Compliance with regulations, and business excellence in the medical device sector. Organizations must make their supplier assessment practice compatible with ISO 13485:2016 and 21 CFR 820 requirements.

This whitepaper delves into the intricacies of supplier assessment from three (3) essential viewpoints: Supplier Selection and Appraisal, Risk-Based Approach, and Performance Monitoring. By knowing and executing these strategies, medical device companies can improve supply chain dependability, mitigate risks, and adhere to Regulatory requirements.

 

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