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.
Risk Inputs in ISO 13485
ISO 13485 Made Simple: Using Risk to Guide Your Quality System ISO 13485 requires that medical device companies use a risk-based approach in their quality systems. That means the more risk something poses to product safety or compliance, the more carefully it needs to...
How-to: Facility Registration
How to Complete FDA Annual Facility Registration: A Step-by-Step Overview This video highlights the step-by-step process for completing the FDA annual facility registration, a mandatory requirement for medical device businesses operating under FDA jurisdiction. The...
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...