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 Caitlin Bates | Jul 3, 2024 | Medical Device Marketing, Software as a Medical Device
Introduction to Email Marketing for SaMD CompaniesUnderstanding Your AudienceSegmenting Healthcare ProfessionalsCreating Buyer PersonasOwning Your Email ListTailoring Messages to Decision-MakersCrafting Compelling Email ContentPersonalization: Making It...
by Jeremy Moore | Jun 11, 2024 | US FDA Regulatory Requirements, International Regulatory Requirement, Software as a Medical Device
Mastering Medical Device Classification: Your Essential Starting PointWhat is Medical Device Classification?Definition and PurposeOverview of Regulatory BodiesWhy Classification of Medical Devices MattersRegulatory ComplianceSafety and EfficacyMarket Access and...
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 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 | Mar 25, 2024 | Software as a Medical Device
Defining Software as a Medical DeviceRegulatory Considerations and Exclusions of SaMDBridging the Gap Between Software Development and Regulatory ComplianceDetermining Whether Your Product Qualifies as Software as a Medical Device (SaMD)First, let’s address the...