How LLMs like ChatGPT Can Simplify Regulatory Affairs for New Medical Devices
The European Union’s Medical Device Regulation (MDR) 2017/745 has significantly transformed the regulatory affairs landscape for medical device manufacturers by establishing strict requirements to ensure the safety and efficacy of devices before they reach the European market. These regulations demand detailed technical documentation, comprehensive clinical evaluations, and proactive post-market surveillance, creating substantial resource and time […]
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