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The FDA recently released a 45-page draft guidance detailing the use of chemical analysis in biocompatibility assessments for medical devices.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…
Health Canada, the FDA, and the UK’s MHRA collaborated in 2021 to establish ten foundational principles aimed at promoting good machine learning practices (GMLP). These principles…
In the complex world of medical device development, the gap between Research and Development (R&D) and Quality Assurance (QA) teams can often lead to significant challenges.…
Overview Artificial intelligence (AI) technologies have ushered in a new era in healthcare, fundamentally altering how medical decisions are made. These advancements extend across various domains…
Design Transfer is the critical process of moving a medical device from prototype or early development to full-scale production. It can be involved in scenarios such…