by Jeremy Moore | Jul 24, 2024 | Quality Management, Compliance and Regulatory Guidance
Introduction to Quality Assurance vs Quality Control in Medical DevicesUnderstanding Quality Assurance (QA) for Medical DevicesWhat is Quality Assurance for Medical Devices?The Role of Quality Assurance in Medical DevicesKey Activities in Quality...
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 | Jun 18, 2024 | Cybersecurity
The Critical Need for DevSecOps in SaMDWhy DevSecOps is Essential for SaMDUnderstanding the Basics of DevSecOps for SaMDThe Unique Challenges of Securing SaMDCore Principles of DevSecOpsWhy DevSecOps for SaMD is ImportantThe Growing Threats in HealthcareBenefits for...