James F. Jordan
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Ask the Expert: Benefits and Challenges of the eStar Submission Process
…eSTAR also accepts combination products and Dual 510(k)/CLIA Waiver IVDs. eSTAR allows submitters to provide comprehensive data for premarket review for various medical devices. Its standardized format helps submitters complete…
…eSTAR also accepts combination products and Dual 510(k)/CLIA Waiver IVDs. eSTAR allows submitters to provide comprehensive data for premarket review for various medical devices. Its standardized format helps submitters complete…
FDA Recognizes AAMI SW96 Cybersecurity Guidance Document
The FDA has officially extended complete recognition to the Association for the Advancement of Medical Instrumentation (AAMI) guidance document on medical device cybersecurity, ANSI/AAMI SW96. Per the FDA, ANSI/AAMI SW96:2023,…
The FDA has officially extended complete recognition to the Association for the Advancement of Medical Instrumentation (AAMI) guidance document on medical device cybersecurity, ANSI/AAMI SW96. Per the FDA, ANSI/AAMI SW96:2023,…
Unlocking Success in SaMD Product Launches Through AI
…notify professionals of global regulatory updates and highlight essential regulatory changes and their implications for product compliance. AI-driven regulatory platforms support SaMD organizations, in particular, by proactively monitoring and adapting…
…notify professionals of global regulatory updates and highlight essential regulatory changes and their implications for product compliance. AI-driven regulatory platforms support SaMD organizations, in particular, by proactively monitoring and adapting…
Caroline Shleifer
Overcoming Barriers to EHR Adoption in Behavioral Health
…community of providers to know about their mental health issues. While we know that physical health and mental health truly do go together, this is not fully embraced or comprehended…
…community of providers to know about their mental health issues. While we know that physical health and mental health truly do go together, this is not fully embraced or comprehended…
The Drivers Boosting Medtech Investments in Cloud-based Digital Transformation
…most pressing concerns, we sponsored the State of Manufacturing Technology survey. This is a free resource that medical device manufacturers can download to benchmark their own businesses and IT strategies…
…most pressing concerns, we sponsored the State of Manufacturing Technology survey. This is a free resource that medical device manufacturers can download to benchmark their own businesses and IT strategies…
Stu Johnson
MedTech Regulatory Intelligence Virtual Summit
…Unique Device Identifiers: The Move Toward UDI-DI and the FDA’s Current Focus in Compliance Efforts Recall Readiness: Best Practices, Required Activities and Challenges Associated with a Product Recall Tuesday, November…
…Unique Device Identifiers: The Move Toward UDI-DI and the FDA’s Current Focus in Compliance Efforts Recall Readiness: Best Practices, Required Activities and Challenges Associated with a Product Recall Tuesday, November…
Leveraging IoT in Medical Waste Management
…share their expertise and best practices with developing nations, aiding in their transition to smart disposal methods. Joint ventures that allow companies to pool resources and expertise to implement and…
…share their expertise and best practices with developing nations, aiding in their transition to smart disposal methods. Joint ventures that allow companies to pool resources and expertise to implement and…
