ARTICLE SUMMARY:
Facing rising international demands around medical device identification, traceability, safety, and surveillance, companies can optimize the way they organize and harness product data for more efficient interaction with regulatory authorities. An expert on new data usage techniques highlights the latest research among medtech company RA professionals to show how to optimize compliance plans. By Sonia A. Veluchamy, Celegence.
Across the life sciences, regulatory affairs (RA) teams face impossible demands on their time, compounded by rising expectations from regulators. The challenge is particularly pronounced in the medical device sector. In medtech, 77% of RA professionals acknowledge they are under-resourced even to meet immediate obligations, let alone soaring requirements as safety controls are increased, according to a 2024 survey of nearly 700 members of the Regulatory Affairs Professionals Society (RAPS) conducted by Celegence.
Strategic use of the latest technology offers a way around these limitations. The new approaches could make lighter work of capturing, organizing, and reusing critical product and manufacturing data, and the way this information is reported to each market’s respective regulatory authorities.
