by Jeremy Moore | May 8, 2024 | Product Development, US FDA Regulatory Requirements
The Nuances of Design Inputs and User Needs in Medical Device DevelopmentPeeling Back the Layers: Understanding User Needs in Medical Device DevelopmentCrafting Solutions Rooted in EmpathyMaximizing ROI: A Simple Paradigm Shift in Approaching Product...
by Jeremy Moore | May 6, 2024 | Cybersecurity, International Regulatory Requirement, Software as a Medical Device, US FDA Regulatory Requirements
Safeguarding SaMDs in an Evolving Cybersecurity LandscapeWhy Cybersecurity for SaMD Companies MattersUnraveling the Ramifications: The Dark Side of Technological Progress in SaMDThe Escalating Importance of Cybersecurity for SaMD CompaniesCommon Cyber Threats...
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:...
