Focused on the comprehensive phases of risk management, this blog will break down the essential steps from risk identification and analysis to control and continuous monitoring. It will illustrate how effective risk management improves device reliability and regulatory acceptance, emphasizing Eunoia Compliance’s expertise in helping manufacturers implement robust systems that align with ISO 14971 and … Read more
This blog will explore the fundamental role of biocompatibility testing in medical device development, including the prevention of adverse biological reactions and compliance with ISO 10993 standards. It will cover how early testing and comprehensive documentation accelerate market approvals and reduce the risk of costly recalls, aligning with Eunoia’s personalized consultancy to ensure products meet … Read more
This blog will discuss recent trends and changes in regulations for medical devices, highlighting the accelerating approval pathways such as FDA 510(k), PMA, and de novo routes. It will emphasize the importance of staying updated with evolving standards worldwide, especially focusing on the European Union’s Medical Device Regulation (MDR) and AI-related regulations, which are reshaping the compliance … Read more