Device Operations Hub
Execution playbooks for medical device teams handling registration, listing, UDI/GUDID, and lifecycle compliance.
FDA LASIK Device Requirements Guide
LASIK device regulatory requirements including PMA, QSR, and UDI.
FDA In Vitro Diagnostic Device Regulation
IVD device regulation and FDA oversight including 510(k), PMA, and LDT policy.
QMSR vs QSR: What Changed for Medical Device Companies in 2026
The Quality Management System Regulation replaced QSR on Feb 2, 2026. Learn what changed, ISO 13485 alignment, and transition requirements.
A Complete Guide to Medical Device FDA Registration in 2026
Step-by-step guide to FDA medical device registration: device classification, establishment registration, 510(k) submissions, QSR requirements, and UDI compliance for domestic and foreign manufacturers.
Medical Device Annual Registration Fees for 2026: What to Expect
MDUFA V sets the FY2026 device establishment registration fee at $7,653. Learn about fee structures, small business considerations, payment deadlines, and what happens if you don't pay.
Medical Device UDI Compliance: Requirements by Device Class
The UDI system requires unique identifiers on all medical device labels. Learn about DI vs PI, GUDID database submissions, compliance timelines by class, and labeling requirements.
QMSR and ISO 13485: What Device Manufacturers Need to Know in 2026
FDA's QMSR replaced the legacy QSR on February 2, 2026, incorporating ISO 13485:2016 by reference. Learn what changed, FDA-specific supplements, and how to comply under the new framework.
De Novo Classification: FDA Pathway for Novel Medical Devices
The De Novo pathway allows novel, low-to-moderate risk devices to be classified as Class I or II without a predicate. Learn the process, how it compares to 510(k) and PMA, and recent trends.
Operate device compliance with fewer surprises
Connect article guidance to service workflows for execution speed.