Case Study: Major Life Sciences Organization achieves faster, standardized 510(k) electronic submission reviews with Appian

Major Life Sciences Organization - Customer Case Study

A major U.S. life‑sciences regulatory authority needed to modernize its submission review operations to respond faster to emerging scientific, technological, and economic trends. Reviews were largely paper‑based and siloed across branches and product areas, with key data trapped in text documents and shared via legacy tools and network drives—hampering productivity, accountability, performance measurement and training.

Using Appian, the agency deployed a digital electronic submissions review application for 510(k) premarket device submissions that integrates with existing systems, automates workflows and standardizes processes. The solution unified legacy functionality, improved data quality and visibility, and delivered a consistent, repeatable review process that increased productivity, accountability and speed of decision‑making.