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 Bryan Bobo | Feb 11, 2026 | Blog
Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed In a recent review exercise, Swissmedic, the Swiss national health authority examined a small set of Notified Body Opinions (NBOps) submitted in...
by Bryan Bobo | Nov 7, 2025 | Blog
Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed The downstream cost of uncoordinated Use Risk Analysis “We already have someone doing the HF work.” It sounds like a sign of progress, but to...
by Bryan Bobo | Oct 24, 2025 | Blog
Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed From Vial to Prefilled Syringe to Autoinjector: How Early-Phase Delivery Decisions Can Make or Break Your Regulatory Timeline Avoiding rework and...
by Bryan Bobo | Jul 10, 2025 | Blog
Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed Pitfalls in Auto-Injector Verification Reports Opening Scenario: The Illusion of Passing Data Imagine you’re reviewing a verification report for...
