Certifications & Inspections

If you assumed FDA inspections would eventually go back to the way they were before COVID, think again. The shift toward hybrid and remote inspections that started during the pandemic has become a permanent part of how the FDA conducts oversight - and it's having a bigger impact on warning letters than most organizations anticipated. In FY2024, remote information requests or failures to respond to them accounted for nearly a quarter of all warning letters issued by the FDA. T

The clock is ticking. On February 2, 2026, the FDA's new Quality Management System Regulation (QMSR) becomes mandatory for all medical device manufacturers. If your organization is still operating under the old Quality System Regulation (21 CFR Part 820), you have just over one year to complete your transition. This isn't a minor regulatory update - it's the most significant change to FDA quality requirements in nearly 30 years. The FDA QMSR replaces 21 CFR Part 820 with ISO

Choosing between ISO 13485 vs ISO 9001 can feel overwhelming, especially when regulatory compliance, market access, and customer requirements all hang in the balance. Both are internationally recognized quality management system (QMS) standards, but they serve different purposes and industries. If you're asking "Do I need ISO 9001 or ISO 13485?" - you're not alone. Many organizations in pharmaceuticals, medical devices, and laboratory testing face this exact decision. The wro