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 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
Training and consulting designed for success within medical device development and risk management
The Top 5 Challenges in Digital Health Solution Development
Modern requirements management can help you respond quickly to new regulations, reduce uncertainty, and bri...
Application of Risk Analysis Techniques in Jama to Satisfy ISO 14971
Tips for Medical Device Companies, Interested in Risk Techniques following ISO 14971, ISO 13485, FMEA, FTA,...