Medical Device Manufacturing

How to Build FDA-Ready Electronics in the U.S.—Without Getting Stuck in Compliance Quicksand

Electronics
Apr 11, 2025
Comments: 0
Navigate the complex journey of bringing high-reliability medical devices to market with our comprehensive guide tailored for startups and OEMs. Learn how to ensure FDA compliance from the start, choose the right EMS partner, and master critical processes like traceability, documentation, and change management. Make your innovation audit-ready and build confidence in every unit.
Explore More

Why Compliance is Critical in Medical Device Manufacturing

Medical device manufacturing
By:
Feb 20, 2025
Comments: 0
Medical Device Manufacturing: 5 Compliance Mistakes That Cost Millions For medical device manufacturers, ensuring regulatory compliance isn’t just about following rules—it’s about patient safety, avoiding legal liability, and keeping products on the market. Non-compliance can result in costly product recalls, FDA warnings, and contract losses. At EST, we specialize in ISO 13485-certified medical device manufacturing, […]
Explore More