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Regulatory
How to Choose Between 510k vs PMA vs De Novo: A Step-by-Step Guide for Medical Devices
Here’s a surprising fact: The FDA has approved or cleared more than 155,000 medical devices since 1976, and all but one percent used the...
The Hidden Reason Medical Device Compliance Fails (And How to Fix It)
Medical device compliance failures occur at rates that would surprise most industry executives. CAPA violations represented nearly...
Medical Device Engineers: The Critical FDA Checklist You’re Missing in Prototype Development
The medical device prototype development industry faces a major hurdle – the dreaded “valley of death” where promising innovations die...
The Hidden Challenges in FDA’s AI Guidance for Medical Devices
FDA authorization records show more than 1,000 AI-enabled medical devices cleared through established regulatory pathways. These...
Decoding the FDA’s Final IVD Rule: Implications for Laboratory Developed Tests
In the realm of healthcare, In Vitro Diagnostic (IVD) products are pivotal, serving as devices or systems designed for diagnosing...
Unpacking the Latest FDA Cybersecurity Requirements for Medical Devices
On March 13, 2024, the FDA announced new draft guidance titled “Select Updates for the Premarket Cybersecurity Guidance: Section 524B of...
The Ultimate Guide to Understanding Class III Medical Devices
Navigating the landscape of medical device regulation in the U.S., the FDA delineates devices into distinct categories: Class I, II, and...
IVD vs Medical Devices: Understanding Their Unique Functions and Regulations
In the rapidly evolving landscape of healthcare technology, IVD (In Vitro Diagnostic) devices and medical devices play crucial roles,...
FDA Regulations Guide for Medical Device Developers
In this episode, “FDA Regulations Guide for Medical Device Developers,” listeners are taken on a comprehensive journey into the intricate...
Compliance Matters: Navigating FDA Clearance and ISO Certification for Medical Devices
In the fast-evolving landscape of medical device development, ensuring safety, efficacy, and regulatory compliance is paramount. Join us...
Compliance and Safety in Medical Device Labeling
Navigating Regulatory Compliance and Design Controls in Medical Device Labeling: A Critical Exploration In the realm of medical device...
MedTech Innovation 360
Podcast
Explore real conversations with engineers, founders, and regulatory experts shaping the future of medical devices. The MedTech Innovation 360 Podcast brings you lessons, insights, and stories from the front lines of innovation.
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