Quality Assurance focuses on internal systems and execution. Regulatory Affairs manages external approvals and regulatory strategy. Both are essential but distinct in scope and often overlapping in practice, especially in small medical device companies.
Streamline your next management review with our free agenda template. Designed to meet both FDA and ISO 13485 requirements, it helps ensure compliance, clear documentation, and efficient oversight without starting from scratch.
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.
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.
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.
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.
ISO 13485 Made Simple: Using Risk to Guide Your Quality System ISO 13485 requires that medical device companies use a risk-based approach in their quality systems. That means the more risk something poses to product safety or compliance, the more carefully it needs to...
How to Complete FDA Annual Facility Registration: A Step-by-Step Overview This video highlights the step-by-step process for completing the FDA annual facility registration, a mandatory requirement for medical device businesses operating under FDA jurisdiction. The...
Are Supplier Audits Required? No Neither ISO 13485 nor FDA 21 CFR explicitly require supplier audits, although supplier audits are one mechanism of qualification. The requirements established in FDA and ISO rules are: • Companies must define evaluation and selection...