7 Questions to Ask Before Choosing QMS Software for Medical Devices

by Jeremy Moore | Sep 17, 2025 | Uncategorized, Compliance and Regulatory Guidance, Fission Software, Quality Management

The Hidden Cost of Choosing QMS SoftwareQuestion 1: Does It Support Continuous Compliance, Not Just Audit Prep?Question 2: How Predictable Are the Costs, Now and as You Grow?Question 3: Is It Designed for Humans, Not Bureaucracy?Question 4: Will It Connect Data and...

What is Design Lifecycle Management? A Modern Approach to Medical Device Development and Compliance

by Jeremy Moore | Sep 10, 2025 | Fission Software, Quality Management

What is Design Lifecycle Management for Medical Devices: A Smarter ApproachThe Problem with Traditional QMS in Medical Device DevelopmentHow DLM Differs from Traditional QMS SoftwareReal-World Benefits of DLM for Medical Device TeamsWhy a Data-First, Integrated...

How to Link Design Inputs to Design Outputs (and Actually Build a Better Device)

by Jeremy Moore | Sep 4, 2025 | Product Development

Why Trace Matrices Fail When Built Too LateWhat It Actually Means to Link Design Inputs to Design OutputsCommon Traceability MistakesStep-by-Step: How to Link Design Inputs to Design Outputs the Right WayWhy Linking Inputs to Outputs Matters for Compliance and...

10 Signs Your Medical Device QMS Is Slowing You Down (And What to Do About It)

by Jeremy Moore | Jul 31, 2025 | Fission Software, Quality Management

Is Your QMS the Bottleneck?Sign #1 – You’re Always Prepping for AuditsSign #2 – Document Chaos ReignsSign #3 – Your System Can’t Scale with Your TeamSign #4 – Manual Processes Are Eating TimeSign #5 – Your QMS Feels Like Bureaucracy, Not...

Document‑Based vs. Data‑Driven QMS: Which Model Fits Your Med‑Device Company?

by Jeremy Moore | Jul 22, 2025 | Fission Software, Quality Management

What is a Data-driven QMS?The Two QMS ArchetypesDocument-Based QMSData-Driven QMSHead-to-Head Comparison of Data-Driven QMS vs, Document-Driven QMSWhen a Document‑Based QMS Still Makes SenseThe Business Case for Data‑Driven QMSTime SavedCost PredictabilityContinuous...