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…
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FDA Draft Guidance on Chemical Analysis for Biocompatibility Assessment of Medical Devices
The FDA recently released a 45-page draft guidance detailing the use of chemical analysis in biocompatibility assessments for medical devices.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…
Enhancing Transparency in Machine Learning – Enabled Medical Devices: Key Principles and Best Practices
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…
Empowering the SDLC with Tools to Bridge R&D and QA Teams
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.…
The FDA’s Artificial Intelligence Program’s Role in Addressing Regulatory Challenges in AI-Driven Medical Devices
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…
Key Strategies for Successfully Executing the Design Transfer Process
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…