Jama Connect® for Digital Health is designed to help you get ramped up quickly with a platform, training, and documentation aligned to industry regulations ISO 13485:2016, 21 CFR 820.30, ISO 62304:2006/AMD 1:2015, and ISO 14971:2019, while applying a proven Systems Engineering approach to product development.
Download this solution overview to see how Jama Connect for Digital Health helps teams view Live Traceability™ across the end-to-end development lifecycle and reduce the effort required to achieve regulatory compliance by providing:
Standard frameworks aligned to key industry regulations
Procedure and configuration guides for medical device design control activities
Export templates for the design history file (DHF) & risk management file
Medical device development and risk management training and consulting services provided by experienced industry professionals.