Jama Software (Portland, Ore.) announced this week that it has introduced new software for medical device development.
The company described Jama Connect as a solution designed to help engineering teams better manage device requirements, risk and design control. The new software is also designed to make regulatory submissions and audit preparations a straightforward process and speed time-to-market with no reduction in quality, according to the company. Features include:
- Standard frameworks aligned to industry regulations ISO 13485:2016, FDA 21 CFR 820.30 and ISO 14971:2019.
- Export templates for the design history file (DHF) and risk management file.
- Best practices, including procedure and configuration guides to manage design controls, verification and validation, risk management, and adhere to relevant FDA, ISO, IEC and EU regulations.
- Ease of on-boarding to set developers up quickly with training and documentation aligned to industry regulations.
“Developers are balancing increased regulatory requirements with device development costs that lead to challenges across the production lifecycle,” said Jama Software chief product officer Josh Turpen in a news release. “We’re excited to introduce our new solution designed specifically for medical device companies which will help ease the development process from the start. Jama Connect allows developers to hit the ground running with preconfigured templates and best practices built-in, saving product teams from the cumbersome and often frustrating process of filing paperwork.”