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May 27, 2025
AI Model Transparency: The Role of Explainable AI (XAI) in Regulatory Approval
AI models in healthcare must not only be accurate but also explainable. Regulators like the FDA, EMA, and NMPA require Explainable AI (XAI) to ensure that AI-driven decisions are understandable, interpretable, and justifiable—especially for high-risk applications like diagnostics.
IT Outsourcing
MedTech
Software
Digital Health
Regulation
May 26, 2025
ISO 13485: Essential Compliance for Medical Device Companies
ISO 13485 is the international standard for quality management systems (QMS) in medical devices. It outlines the requirements for designing, developing, manufacturing, and distributing medical devices that consistently meet regulatory and customer requirements. Compliance with ISO 13485 is essential for market access, regulatory approval, and ensuring product safety and effectiveness.
Regulation
MedTech
Medical Devices
May 26, 2025
ISO 14971: Risk Management for Medical Devices
ISO 14971 is the international standard for risk management in medical devices, providing a structured approach to identifying, evaluating, and controlling risks throughout the product lifecycle. Compliance with ISO 14971 is essential for meeting regulatory requirements such as the FDA’s Quality System Regulation (QSR), the EU Medical Device Regulation (MDR), and ISO 13485. Implementing a strong risk management system helps companies reduce product failures, enhance patient safety, and ensure regulatory approval.
Regulation
MedTech
Medical Devices
May 25, 2025
Quantitative Risk Assessment Models in Medical Devices
Quantitative risk assessment (QRA) models are essential tools for evaluating and managing risks in medical device development. Unlike qualitative methods, which rely on subjective judgment (e.g., low, medium, high risk), QRA assigns numerical values to risk factors, allowing for data-driven decision-making. This approach is crucial for meeting regulatory standards like ISO 14971, FDA QSR, and EU MDR, ensuring objective risk evaluation, better risk control, and compliance
Regulation
MedTech
Medical Devices
May 24, 2025
Failure Modes and Effects Analysis (FMEA) in Medical Devices
Failure Modes and Effects Analysis (FMEA) is a structured risk management method used to identify and prevent potential failures in medical devices. It is widely used to comply with ISO 14971, FDA QSR, and EU MDR by systematically analyzing failure risks, prioritizing them, and implementing controls to enhance patient safety and device reliability.
Regulation
MedTech
Medical Devices
May 22, 2025
Commercializing an EDC Platform: Lessons Learned from MedTech Product Builders
In the fast-evolving medtech landscape, Electronic Data Capture (EDC) platforms are essential for clinical trials, post-market surveillance, and regulatory compliance. But building one is just the beginning. Turning an EDC platform into a viable commercial product is a different challenge altogether. At ITR VN, we’ve partnered with multiple European and North American companies to help develop and scale their EDC platforms. We’ve seen first-hand what works—and what doesn’t. Here’s a look at the real-world journey from prototype to product.
Digital Health
MedTech
PCB Design
Firmware
IT Outsourcing
May 21, 2025
Designing Miniaturized, Ultra-Low-Power, and Biocompatible PCBs for Wearable and Implantable MedTech Devices
As medical technology advances, miniaturized PCBs with ultra-low-power consumption, wireless charging, and extreme biocompatibility are becoming critical for next-generation wearable and implantable devices. These technologies enable continuous health monitoring, real-time data transmission, and long-term patient comfort. However, achieving these features presents significant design and engineering challenges.
Firmware
Medical Devices
MedTech
IT Outsourcing
PCB Design
May 20, 2025
ISO/IEC 42001: The First AI Management Systems Standard
As artificial intelligence (AI) becomes more integrated into critical sectors like healthcare, finance, and manufacturing, organizations face increasing regulatory and ethical scrutiny. ISO/IEC 42001, published in December 2023, is the first international standard for AI Management Systems (AIMS), providing a structured framework for governing, managing, and deploying AI systems responsibly
IT Outsourcing
Digital Health
MedTech
Medical Devices
IoT
May 16, 2025
Beyond Prototypes: How to Design a MedTech Product for Mass Manufacturing
Bringing a MedTech product from prototype to mass production is a complex process that requires more than just technical feasibility. Regulatory compliance, cost-efficient design, and scalable manufacturing are critical to success. Without the right strategy, companies risk delays, high costs, and compliance failures. This guide covers the key steps to ensure a smooth transition from prototype to mass manufacturing while meeting FDA, MDR, and ISO 13485 standards.
Medical Devices
Regulation
MedTech
Software
IT Outsourcing
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