Blog

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
Oct 23, 2024
3 min read

FDA Draft Guidance on Chemical Analysis for Biocompatibility Assessment of Medical Devices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
Sep 18, 2024
2 min read

Elevate Your Compliance with Rook Quality Systems’ “Quality as a Service” Offering
Aug 28, 2024
2 min read

Empowering the SDLC with Tools to Bridge R&D and QA Teams
Jul 21, 2024
2 min read

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
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
Jun 26, 2024
2 min read

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
Jun 07, 2024
4 min read

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
May 10, 2024
2 min read

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
Apr 11, 2024
2 min read


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
Mar 06, 2024
1 min read

QMSR Final Rule Webinar
Feb 16, 2024

FDA Proposes New Regulations For Laboratory Developed Tests
Feb 13, 2024
1 min read



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
Nov 06, 2023
3 min read

Road to Market for Wearable Medical Devices
Nov 03, 2023
5 min read