The life sciences and healthcare sectors rank among the world's most tightly regulated industries, with a regulatory landscape that is constantly evolving. Globalization, rapid advances in science and technology, and the drive to improve patient outcomes and safety have fueled ongoing changes. Patient and consumer expectations are becoming increasingly sophisticated and demanding, with a greater emphasis on personalized, patient-centric experiences and the sharing of information about conditions and treatments. In clinical research, trial participants are now viewed as collaborators rather than mere subjects.
Adapting to new regulatory requirements is crucial for companies' commercial viability and reputation, and the ability to respond quickly and efficiently is vital. However, the transition can be challenging, especially for companies with fragmented systems and siloed data that now need to be aligned and integrated.
This paper focuses on the ever-changing regulatory environment in the medical devices industry and the corresponding obligations that medical device organizations must comply with. Although the in-vitro diagnostics (IVD) sector has also undergone significant regulatory changes, it falls beyond the scope of this paper.
Medidata has identified several key themes in managing medical device data that are crucial to advancing product development, driving innovation, and improving treatments for patients and consumers.
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