Top 5 Challenges in Medical Device Regulatory Affairs (And How to Overcome Them)
In the highly regulated world of healthcare, medical device regulatory affairs play a critical role in ensuring safety, efficacy, and compliance of devices. However, navigating the regulatory landscape is no easy task. Companies must address a myriad of challenges to bring their devices to market while adhering to global standards. Here, we outline the top five challenges in medical device regulatory affairs and provide actionable strategies to overcome them.