by Jonathan Amaya-Hodges | Jul 14, 2026 | Blog
Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed EU COMBINE Pilot Expands to Cover Investigational Devices and ATMP Combination Studies Quick take: Phase 2 of the European Commission’s COMBINE...
by Lori Skope | Jul 14, 2026 | Blog
Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed Navigating FDA, Reliability, and Quality Leadership | with Jeff Gensler Welcome to the first episode of the Navigating the Combination podcast! When...
by Max Lerman | Jun 8, 2026 | Blog
Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed Vendor Selection and Bridging Strategy How Upstream Vendor Decisions Shape Downstream Clinical, Regulatory, and Commercial Outcomes Executive...
by Bryan Bobo | May 13, 2026 | Blog
Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed Consider a combination product program that has navigated early development successfully. Design inputs established, verification testing underway,...
by Andrew Ozga | May 11, 2026 | Blog
Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed Why Design Input Requirements Decide Program Outcomes [and how to get them right] Design input requirements (DIRs) are rarely where leadership...
