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April 16, 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 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
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
April 9, 2025
510(k) Clearance Simplified: Avoiding Costly Mistakes in MedTech Approvals
How 510(k) clearance helps wearable medical devices enter the U.S. market faster when to use it vs. De Novo or PMA, and how to prepare your FDA submission.
Blog
MedTech
April 9, 2025
Low-Power Design Strategies for Cellular IoT Devices - Part 2
Optimize power efficiency in wearable & IoT devices with smart firmware, OTA updates, and adaptive design by ITR – your reliable tech partner in MedTech.
Blog
Medical Devices
April 8, 2025
What is De Novo Classification for Wearable Medical Devices?
Explore with ITR how the FDA De Novo classification enables first-of-its-kind wearable medical devices to enter the market with a clear, risk-based approval path.
Blog
Regulation
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