The Impact of MDCG 2024-10 on Internal Processes, Timelines, and Team Readiness
The introduction of the MDCG 2024-10 guideline in June 2024 marks a significant shift in how orphan medical devices are evaluated and brought to market in the European Union. This […]
How to Streamline Clinical Evaluation Reports for Medical Devices
In the ever-evolving landscape of medical device regulation, Clinical Evaluation Reports (CERs) play a pivotal role in ensuring compliance with the Medical Device Regulation (MDR). For Regulatory Affairs executives, the […]
Enhancing Regulatory Submissions through AI: Innovations in Medical Writing
The landscape of regulatory writing in the medical sector is undergoing a significant transformation, driven by advances in Artificial Intelligence (AI). As regulatory requirements become increasingly complex and voluminous, the […]
