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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...
Boost Medical Device Market Speed Without Compromising Quality Assurance
In the fast-paced world of medical device development, striking a balance between speed to market and quality assurance is crucial. The...
8 Critical Team Roles for AI Medical Device Development
The AI medical device market stands at $10.4 billion and will grow 38.4% yearly through 2030. AI now revolutionizes healthcare through...
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...
What’s Trending in Medtech? Discover the Latest Innovations
The medical technology industry is currently navigating a complex landscape characterized by both groundbreaking advancements and...
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On March 13, 2024, the FDA announced new draft guidance titled “Select Updates for the Premarket Cybersecurity Guidance: Section 524B of...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,...
5 Key Steps in Engineering for Innovative Medical Device Development
Navigating through the intricate phases of medical device development is crucial for bringing innovative products to market efficiently...
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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