Blog
FDA eSTAR Program: Three Main Benefits
More than a year ago, we explained the main benefits of the FDA eSTAR Program for 510(k) and De Novo filings. This information remains accurate, and…
Breaking Down the FDA Draft Guidance on Lifecycle Management and Marketing Recommendations for AI-Enabled Devices
The FDA’s draft guidance, “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations,” supports a Total Product Lifecycle (TPLC) approach to overseeing AI-driven medical…
Key Insights Into the FDA’s Updated GUDID Guidance
On December 17th, 2024, the Food and Drug Administration (FDA) issued an updated final guidance on submitting data to the Global Unique Device Identification Database (GUDID)…
4 Bold Predictions Shaping Medical Device Quality in 2025
As 2025 approaches, the medical device industry stands on the brink of transformative changes. To help you stay ahead, we asked our CEO and Founder, Kyle…
Don’t Wait – Schedule Your 2024 Internal Audit with RookQS Today!
As 2024 wraps up, many companies are scrambling to complete their internal audits before the end of the year. The internal audit process plays a vital…
Understanding How to Properly Evaluate Suppliers per FDA Requirements 21 CFR 820.50
Purchasing Controls and Supplier Evaluations are a critical component of quality management for medical device manufacturers, ensuring that materials, components, and services provided by third parties…
Small Business Determination Requests Now Accepted Through CDRH Portal
The FDA recently released a significant update to its Center for Devices and Radiological Health (CDRH) Portal, allowing medical device companies to send premarket submissions and…
FDA Draft Guidance on Chemical Analysis for Biocompatibility Assessment of Medical Devices
The FDA recently released a 45-page draft guidance detailing the use of chemical analysis in biocompatibility assessments for medical devices. This guidance provides manufacturers with critical…
Advancing Innovation in Sterilization Processes: FDA’s Recognition of New Standards
In a pivotal move to support the ongoing innovation in sterilization processes, the U.S. Food and Drug Administration (FDA) recently recognized three new international standards. These…
Elevate Your Compliance with Rook Quality Systems’ “Quality as a Service” Offering
In today’s fast-paced and highly regulated market, maintaining compliance and ensuring top-tier quality is more critical than ever. However, for many companies, managing these processes internally…
Expanding Horizons: Rook Quality Systems Now Offering Product Registration and License Holding Services in APAC
At Rook Quality Systems (RookQS), our mission is to provide unparalleled regulatory and quality support to the medical device industry. We’re excited to announce the expansion…