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Glossary Term
External Audit
Definition
An External Audit is an independent examination of a company’s operations, processes, and compliance with applicable standards, regulations, and quality management systems. Conducted by third-party organizations, such as Notified Bodies or regulatory agencies, external audits assess whether a company meets industry requirements for medical device safety, effectiveness, and quality.
Relevance to the MedTech Industry
External audits ensure that MedTech companies adhere to regulatory and quality standards, such as ISO 13485, FDA 21 CFR Part 820, or EU MDR. They provide a critical mechanism for maintaining product safety, reliability, and regulatory compliance, ultimately protecting patient health and enhancing trust in medical technologies.
Additional Information & Related Terms
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