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Learn FDA Class I medical device rules, examples, and compliance tips to ensure safety, quality, and regulatory success in low-risk healthcare tools.

Discover low-power design strategies for cellular IoT devices using NB-IoT, PSM, eDRX, and smart hardware to extend battery life.

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).

Learn key considerations to build scalable, secure, and energy-efficient multifunctional IoT devices that transform industries and enhance user experience.

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.

Optimize power efficiency in wearable & IoT devices with smart firmware, OTA updates, and adaptive design by ITR – your reliable tech partner in MedTech.

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.

Explore with ITR how Cellular IoT is revolutionizing MedTech through remote monitoring, real-time data, secure connectivity, and smarter healthcare delivery.

Electronics in medical devices enable advanced diagnostics, real-time monitoring, and improved therapies. ITR VN supports Medtech with embedded systems, compliance, and innovation.