by Jeremy Moore | Apr 17, 2024 | Product Development, Software as a Medical Device
Exploring the Intersection: Agile Methodologies in Medical Device Software DevelopmentUnderstanding Traditional Development MethodsIntroduction to AgileChallenges of Implementing Agile in Medical Device Software DevelopmentImplementing Agile in Medical Device...
by Jeremy Moore | Apr 1, 2024 | Product Development, US FDA Regulatory Requirements
From Concept to Market: A 7-Step Process to FDA Approval for Medical DevicesStep 1: User Needs AnalysisStep 2: Risk Analysis and Risk ManagementStep 3: Defining Product-Specific Requirements (Design Inputs)Step 4: Designing the Product (Design Outputs)Step 5:...
