medical device

All articles tagged “medical device”.

How to Prepare for an FDA Inspection of Your Medical Device QMS

An FDA inspection of a medical device company’s quality management system (QMS) can be a daunting experience. However, with proper preparation and attention to detail, you can ensure that your company is ready for the inspection. In this article, we will provide you with tips and best practices for preparing for an FDA audit of […]

Are ISO 13485 and FDA 21 CFR Part 820 audits the same?

Factory Audits/Quality Control

Our recent newsletter Feature Article highlighted ISO 13485 audits applicable to the medical device industry. A common question we receive in relation to regulatory requirements in the U.S. is the relationship to FDA 21 CFR Part 820. To ensure medical devices are safe and effective, the U.S. Food and Drug Administration regulates current good manufacturing […]

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