Latest Articles
Explore our most recent posts below, and be sure to check back often for new content that can help you streamline your operations and achieve success in the competitive medical device market.
When a Line Extension Becomes a New Device
A recent FDA warning letter shows what separates a defensible letter to file from a thin one. The difference is the design change assessment behind it, and how well it connects to complaints and CAPA.
A New Statutory Attempt at LDT Oversight
HR 8890 would keep LDT oversight with CMS under CLIA and add a public validation database, serious harm reporting, and optional third-party review.
RUOs, LDTs, and FDA Enforcement
Despite the 2025 court decision vacating the FDA’s LDT Final Rule, labs and manufacturers aren’t off the hook. This article explores how the FDA is shifting enforcement to RUO labeling and IVD misuse to maintain oversight of unregulated diagnostics.
What is the difference between RA & QA?
What’s the Difference Between Quality Assurance and Regulatory Affairs? If you’re navigating compliance in a small or early-stage medical device company, chances are you’ve come across two essential terms: Quality Assurance (QA) and Regulatory Affairs (RA). These...
How to Hold a Management Review
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.
How to Find a Contract Manufacturer
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.