Jama Software, the leading requirements management solution for building complex products and integrated systems, today introduced Jama Connect for medical device development, a new solution designed to help engineering teams better manage device requirements, risk and design control all on one powerful platform. The newest release makes regulatory submissions and audit preparations a straightforward process, speeding time-to-market deployment with no reduction in quality.

Evolving regulations in both the US and Europe, and the need to adhere closely, puts quality and compliance ahead of time-to-market for device manufacturers. In this continuously changing environment, engineering teams are under pressure to move quickly while simultaneously maintaining product quality and improving management processes along the way. Paired that with the fact that costs associated with recalls for a single device can be as much as $600 million, demonstrates just how vital it is that teams stay aligned. Jama Software, used by seven of the top 10 global medical device companies, recognizes these challenges and has been working closely with companies in the industry to offer an all-in-one solution. Jama Connect for Medical Device Development helps engineering teams get established quickly, allowing them to focus on product design, development, innovation, and helps to reduce the costs and effort involved in preparing for audits.

“Developers are balancing increased regulatory requirements with device development costs that lead to challenges across the production lifecycle,” said Josh Turpen, Chief Product Officer at Jama Software. “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.”

Medical Devices have become increasingly complex and integrated systems. As a result, managing device requirements, conducting risk assessments and ensuring design control with spreadsheets and documents is no longer viable,” said Daniel R. Matlis, President of Axendia, a leading life-science analyst firm. “Medical Device Manufacturers must leverage integrated platforms that enable them to focus on the introduction of innovative, high-quality products that improve patient outcomes while ensuring compliance to applicable regulatory requirements cost-effectively.”

Source: Company Press Release