Jama is a modern solution for product development, requirements and test management. It allows for enterprise-wide collaboration on product development. It is strategic – and social – a single source of truth about the products you’re developing.

The AMDD and Jama partnership is for companies that are new to developing regulated products, are lacking a well-defined development process, or want to digitize a document-based requirements management process. The solution provided by AMDD and Jama eases the path to regulatory compliance by ensuring teams get up and running quickly based on a process tightly aligned to governing regulations ISO 13485:2016 and 21 CFR 820.30. We provide an out-of-the-box configuration designed to reflect medical-device development best practices, along with training and documentation templates for relevant key assets required for Design History File (DHF) assets.

Jama software is key for AMDD to implement the ethos of agile development methodology in medical devices. We apply this this in all engineering disciplines (Human Factors, Electrical Engineering, Mechanical Engineering, Software Engineering and System Engineering) to solve complex medical device development and design challenges.