Remote Internal Audit of QMS Systems for 21 CFR 820 and ISO 13485:2016 Compliance

A leading US-based medical device manufacturer approached Freyr for QMS audit support for 21 CFR 820 and ISO 13485:2016 compliance. Amidst the current pandemic conditions, Freyr conducted a remote internal QMS audit through a strategic, phase-wise approach, as per the defined regulations in scope, with meticulous planning and by deploying certified auditors.

Download the case study to decipher how Freyr performed on-time and compliant remote internal audits for the QMS systems.

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