Best Practices For Medical Device Firms Preparing for and Responding to an FDA Audit

October 10, 2022

As a manufacturer of an FDA-registered Class II or Class III medical device, the FDA may conduct an inspection of your organization at any time. In other words, your company is subject to random, unscheduled inspections. Reasons for an inspection may include a routinely scheduled investigation, an accumulation of incident reports or consumer complaints, or […]

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