by Jeremy Moore | Dec 31, 2024 | Software as a Medical Device
Why SaMD Trends and Best Practices in 2025 Will Define Your SuccessKey SaMD Trends Shaping the Landscape in 20251. AI and Machine Learning Are Reshaping SaMD Trends2. Cybersecurity Is No Longer Optional—It’s Critical3. Global Expansion Made Easier with Harmonized...
by Jeremy Moore | Oct 16, 2024 | Software as a Medical Device, Product Development
Navigating the Complexities of SaMD Development ChallengesSaMD Development Challenge 1: Regulatory Compliance and Navigating Changing RegulationsSaMD Development Challenge 2: Ensuring Patient Safety and Risk ManagementSaMD Development Challenge 3: Aligning with...
by Jeremy Moore | Aug 20, 2024 | Software as a Medical Device
Streamlining Medical Device Manufacturing with Lean Product DevelopmentThe Transformative Potential of AI in SaMDKey OpportunitiesConsiderations and ChallengesData Privacy and Security Regulatory Compliance Ethical Concerns Technical and Infrastructure Challenges Loss...
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...
