Tet 2023 - Employee Activities

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.

The journey to bring a Medtech device to market is increasingly complex, requiring seamless coordination between specialized partners like Contract Research Organizations (CROs) and Contract Manufacturers (CMs). However, managing these partners in silos often leads to costly mistakes and delays, from designs that are unfit for manufacturing to a disconnect between clinical and technical requirements. This article provides a deep dive into the challenges of orchestrating a partner ecosystem and reveals why engaging a central R&D partner, acting as an "ecosystem orchestrator," is the key strategy to mitigate risk, optimize resources, and ensure your project's success.

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.