by Jeremy Moore | May 6, 2025 | Compliance and Regulatory Guidance, Fission Software, International Regulatory Requirement
Europe Just Threw Down the Gauntlet on Regulatory SubmissionsWhy This Matters to You — Even If You’re not in EuropeWhat MedTech Europe Is Actually Asking For (And Why It’s a Game-Changer)How Fission’s Already Doing This, And Why That’s a Big DealThe Bigger Shift: From...
by Jeremy Moore | Oct 23, 2024 | International Regulatory Requirement, US FDA Regulatory Requirements
Why a US Agent for FDA Submissions is essential: From 510(k) to PMAWhat Is a 510(k) Submission?The Role of a US Agent in the 510(k) ProcessWho Is a US Agent?Responsibilities of a U.S. AgentHow to Choose the Right U.S. Agent for Your 510(k) SubmissionRegulatory...
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...
