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April 19, 2025
FDA Class 3 Medical Devices: High-Risk Products & Regulatory Pathway
Learn about FDA Class 3 medical devices, their high-risk nature, regulatory requirements, and compliance strategies. ITR VN supports manufacturers in navigating the complex Premarket Approval (PMA) process for market success.
Blog
Regulation
April 18, 2025
What You Need to Know About FDA Class 2 Regulations: Moderate-Risk, Enhanced Oversight
Discover FDA Class 2 medical devices, their regulations, real-world examples, and effective compliance strategies. ITR VN supports FDA-compliant device development, ensuring safety and market readiness.
Blog
April 17, 2025
ITR Meets The Institute of Biomedical Physics - Military Medical Department
On April 15, 2025, representatives from ITR held an official meeting with the Institute of Biomedical Physics, an entity under the Military Medical Department of the General Department of Logistics, at the Institute’s headquarters. The meeting served not only as a platform for both sides to share their capabilities but also to lay the groundwork for a strategic collaboration in the development of EMG (Electromyography)-based medical devices - a technology with immense potential in rehabilitation and personalized healthcare.
News
April 12, 2025
What You Need to Know About FDA Class 1 Regulations: Low-Risk Devices
Learn FDA Class I medical device rules, examples, and compliance tips to ensure safety, quality, and regulatory success in low-risk healthcare tools.
Blog
Regulation
April 11, 2025
ITR at Vietnam Spain Business Summit | MedTech & Digital Health Partnership
ITR joins Vietnam Spain Business Forum, supporting stronger economic ties and long-term collaboration between Spanish and Vietnamese businesses.
News
April 11, 2025
How 5G and NB-IoT are Changing the IoT Landscape
Discover how 5G and NB-IoT are transforming IoT with real-time speed, low power, and wide coverage unlocking smarter cities, healthcare, logistics, and more.
Blog
MedTech
April 9, 2025
Power-Saving Strategies for Cellular IoT Devices (Part 1)
Discover low-power design strategies for cellular IoT devices using NB-IoT, PSM, eDRX, and smart hardware to extend battery life.
Blog
Firmware
Medical Devices
April 9, 2025
FMEA - The process medical device startup founders need to know
Understanding FMEA is not only a best practice; it’s a practical gateway into ISO 14971 (risk management for medical devices) and 21 CFR Part 820 (the FDA's quality system regulation).
Blog
Medical Devices
April 9, 2025
Key Considerations for Developing a Multifunctional IoT Device
Learn key considerations to build scalable, secure, and energy-efficient multifunctional IoT devices that transform industries and enhance user experience.
Blog
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