by Jeremy Moore | Jul 19, 2024 | Software as a Medical Device, Compliance and Regulatory Guidance, Product Development
Unlocking Regulatory Success: 510(k) vs De Novo Pathways for SaMDUnderstanding the 510(k) PathwayDefinition and Background of the 510(k) Pathway:Requirements of the 510(k) Pathway:Process for the 510(k) Pathway:Advantages of the 510(k) Pathway:Limitations of the...
by Jeremy Moore | Jul 12, 2024 | Product Development, Compliance and Regulatory Guidance
Why Risk Management is a Game-Changer for Medical DevicesUnderstanding Risk ManagementWhat is Risk Management for Medical Devices?Why is Risk Management Crucial in the Medical Device Industry?Key Components of Risk Management for Medical DevicesRisk Identification:...
by Jeremy Moore | Jun 26, 2024 | Product Development
Bridging the Gap Between Ideas and RealityAssessing the Value of Your IdeaIdea Validation (or Invalidation): Is Your Concept Worth Pursuing?Market Research and AnalysisBroaden Your Audience:Utilize Online Platforms:Feasibility StudyRegulatory...
by Jeremy Moore | May 22, 2024 | Product Development
An Introduction to Remediation in Medical Device DevelopmentUnderstanding Remediation in Medical Device DevelopmentWhy Remediation in Medical Device Development Matters:The Cost of Neglecting Good Design Practices in Medical Device DevelopmentRegulatory Impact:Risks...
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 | 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...