Latest Articles
Explore our most recent posts below, and be sure to check back often for new content that can help you streamline your operations and achieve success in the competitive medical device market.
How to Hold a Management Review
Streamline your next management review with our free agenda template. Designed to meet both FDA and ISO 13485 requirements, it helps ensure compliance, clear documentation, and efficient oversight without starting from scratch.
How to Find a Contract Manufacturer
Learn how to search the FDA Establishment Registration & Listing database to verify device manufacturers, suppliers, and contract partners. Practical tips for quality and regulatory professionals.
Warning Letters
Update: This post was written in October 2024 when FDA first announced the action. FDA has since gone further, rejecting all study data from both facilities, and we have written a fuller piece on what this means for your supplier qualification program. For the current...
LDT 5 Stages of Grief
Quite a few LDT companies are in the Anger and Denial phases, while some have progressed to Bargaining. The companies that are poised for success though are already in the Acceptance phase and moving forward with developing their QMS. It is likely that the final rule...
Amazon FBA Review Issues
Did you know we can help with Amazon FBA regulatory review issues? Recently, there has been an increase in inquiries related to Amazon flagging or removing health-related products and medical devices due to regulatory concerns. This uptick in issues aligns with the...
Devices are Trending
In recent years, a significant trend has been emerging in the healthcare landscape. Medical devices, traditionally seen as secondary tools or adjuncts to therapeutic interventions, are increasingly becoming primary treatments for conditions that were once managed...