What FDA Expects in a 510(k) Submission: Lessons from eSTAR
FDA's eSTAR template does more than digitize your 510(k) submission. It reveals exactly what reviewers expect to see, section by section, from your device description through your cybersecurity documentation. Manufacturers who read eSTAR as a blueprint instead of a form are the ones who move through review faster, with fewer Additional Information requests.
The IEC 60601 4th Edition Transition: What Medical Device Manufacturers Need to Know
IEC 60601-1 is getting its biggest update in nearly two decades. Here's what the 4th Edition changes, why it matters for software-driven and connected devices, and how manufacturers can start preparing now.
Borderless MedDev at American Academy of Pediatrics (AAP) 2025
CSO Scott Blomberg joined Dr. Mary Blomberg, pediatrician for annual event.
Brodie Pedersen, CRO for Borderless MedDev speaks at the 2021 EMC Minnesota Event
It all begins with an idea.
FDA Truisms Part 1: Documentation Lesson from “Spirit in the Sky"
It all begins with an idea.