Features
This article explores life-cycle activities for machine learning (ML) within regulated life sciences. It positions and contextualizes the life cycle and management of the machine learning subsystem or components within a wider system life cycle. It also gives general descriptions and guidance illustrated by a case study demonstrating a machine learning application to medical image recognition, or software as a medical device (SaMD).1
- 1International Society for Pharmaceutical Engineering. GAMP® Good Practice Guide: Regulated Mobile Applications. North Bethesda, MD: International Society for Pharmaceutical Engineering, 2014.