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Understanding How to Properly Evaluate Suppliers per FDA Requirements 21 CFR 820.50
Audit Support
Understanding How to Properly Evaluate Suppliers per FDA Requirements 21 CFR 820.50
Oct 25, 2024 3 min read
Small Business Determination Requests Now Accepted Through CDRH Portal
Small Business Determination Requests Now Accepted Through CDRH Portal
Oct 23, 2024 3 min read
FDA Draft Guidance on Chemical Analysis for Biocompatibility Assessment of Medical Devices
FDA Draft Guidance on Chemical Analysis for Biocompatibility Assessment of Medical Devices
Sep 26, 2024 3 min read
Advancing Innovation in Sterilization Processes: FDA’s Recognition of New Standards
Advancing Innovation in Sterilization Processes: FDA’s Recognition of New Standards
Sep 18, 2024 2 min read
Elevate Your Compliance with Rook Quality Systems’ “Quality as a Service” Offering
General
Elevate Your Compliance with Rook Quality Systems’ “Quality as a Service” Offering
Aug 28, 2024 2 min read
Expanding Horizons: Rook Quality Systems Now Offering Product Registration and License Holding Services in APAC
News
Expanding Horizons: Rook Quality Systems Now Offering Product Registration and License Holding Services in APAC
Aug 09, 2024 2 min read
Enhancing Transparency in Machine Learning – Enabled Medical Devices: Key Principles and Best Practices
Enhancing Transparency in Machine Learning – Enabled Medical Devices: Key Principles and Best Practices
Aug 01, 2024 4 min read
Empowering the SDLC with Tools to Bridge R&D and QA Teams
Empowering the SDLC with Tools to Bridge R&D and QA Teams
Jul 21, 2024 2 min read
The FDA’s Artificial Intelligence Program’s Role in Addressing Regulatory Challenges in AI-Driven Medical Devices
The FDA’s Artificial Intelligence Program’s Role in Addressing Regulatory Challenges in AI-Driven Medical Devices
Jul 19, 2024 2 min read
Key Strategies for Successfully Executing the Design Transfer Process
Key Strategies for Successfully Executing the Design Transfer Process
Jul 12, 2024 4 min read
Essential Tips for Preparing for Your ISO 13485:2016 Stage 1 Audit
Essential Tips for Preparing for Your ISO 13485:2016 Stage 1 Audit
Jul 11, 2024 3 min read
Mastering Cybersecurity in Medical Devices: Key Strategies and Tools
Jul 10, 2024 1 min read
Understanding the FDA’s Small Entity Compliance Guide for the LDT Final Rule
Understanding the FDA’s Small Entity Compliance Guide for the LDT Final Rule
Jun 26, 2024 2 min read
What is A Pre-Submission (Pre-Sub)?
What is A Pre-Submission (Pre-Sub)?
Jun 10, 2024 3 min read
Keeping Up with the Machine: Predetermined Change Control Plans for Medical Devices
Keeping Up with the Machine: Predetermined Change Control Plans for Medical Devices
Jun 07, 2024 4 min read
Navigating the Intricacies of Medical Device Software Regulations
Navigating the Intricacies of Medical Device Software Regulations
Jun 04, 2024 1 min read
FDA Labeling Requirements for Point of Care vs. Home Use Devices
FDA Labeling Requirements for Point of Care vs. Home Use Devices
May 10, 2024 2 min read
Navigating the FDA’s Final Rule on Lab-Developed Tests – LDTs
Navigating the FDA’s Final Rule on Lab-Developed Tests – LDTs
May 03, 2024 2 min read
Navigating Healthcare Cybersecurity: Section 524B of the FD&C Act
Navigating Healthcare Cybersecurity: Section 524B of the FD&C Act
Apr 11, 2024 2 min read
Streamlining Success: Rook Quality Systems’ Comprehensive Clinical Evaluation Services for Medical Device Clients
Streamlining Success: Rook Quality Systems’ Comprehensive Clinical Evaluation Services for Medical Device Clients
Apr 11, 2024 2 min read
RookQS and Grasp Health Forge Dynamic Partnership
News
RookQS and Grasp Health Forge Dynamic Partnership
Apr 11, 2024 1 min read
A Guide to Etiquette and Preparation for Your First FDA Audit
A Guide to Etiquette and Preparation for Your First FDA Audit
Mar 08, 2024 1 min read
Guidelines for Verifying Laboratory Testing Data Before FDA Submission
Guidelines for Verifying Laboratory Testing Data Before FDA Submission
Mar 06, 2024 1 min read
QMSR Final Rule Webinar
QMSR Final Rule Webinar
Feb 16, 2024
FDA Proposes New Regulations For Laboratory Developed Tests
FDA Proposes New Regulations For Laboratory Developed Tests
Feb 13, 2024 1 min read
6 Bold Predictions for Medical Device Quality in 2024
Cybersecurity MDR
6 Bold Predictions for Medical Device Quality in 2024
Jan 26, 2024 2 min read
Rook QS Joins Forces with Trust Cybersecurity for Unparalleled Defense
News
Rook QS Joins Forces with Trust Cybersecurity for Unparalleled Defense
Jan 13, 2024 1 min read
Understanding the FDA Changes to LDT Regulations
Understanding the FDA Changes to LDT Regulations
Dec 05, 2023 3 min read
FDA’s Move to Lower 510(k) Submissions to Aid Virtual Health Care
FDA’s Move to Lower 510(k) Submissions to Aid Virtual Health Care
Nov 06, 2023 3 min read
Road to Market for Wearable Medical Devices
Road to Market for Wearable Medical Devices
Nov 03, 2023 5 min read

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