Learn how to search the FDA Establishment Registration & Listing database to verify device manufacturers, suppliers, and contract partners. Practical tips for quality and regulatory professionals.
2025 FDA Warning Letter Trends
FDA warning letters in the first half of 2025 highlight recurring issues with Medical Device Reporting and complaint handling. From missing procedures to delayed submissions, the same preventable mistakes appear again and again putting companies at risk.
What is a Risk-Based Approach?
Risk-based thinking is more than a buzzword, it is the foundation of a smart and effective QMS. This post shows how to apply risk-based thinking practically across audits, CAPAs, supplier management, and training, so you can prioritize what matters, avoid unnecessary compliance burdens, and become a true strategic partner.
What Does GMP-Exempt Mean?
GMP exemption status is often overlooked but critically important in medical device classification. This post explains how it affects your quality system obligations, which are separate from product classification, and why checking that field in the FDA database can reshape your compliance and documentation strategy.