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
Regulatory Shift for Machine Learning in Software as a Medical Device (SaMD)
Machine Learning in Software as a Medical Device Machine learning (ML), a subset of artificial intelligence...
MDR challenges remain as regulation goes into effect: MedTech Europe
Editor’s Note: This posts on EU MDR was originally published here by MedTech Drive and written by Greg Slab...