The FDA’s draft guidance, “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations,” supports a Total Product Lifecycle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…
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)…
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…
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…
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…
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…
The FDA recently released a 45-page draft guidance detailing the use of chemical analysis in biocompatibility assessments for medical devices.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…
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…
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…
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…