Evolving regulations in both the United States 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 recognizes these challenges and has been working closely with companies in the medical device 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.”
Normally, products can undergo multi-month-long review cycles. However, technology, when properly leveraged, can reduce that review cycle by as much as 75 percent. Jama Connect for Medical Device Development accelerates the development lifecycle with key features including:
- 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 onboarding to set developers up quickly with training and documentation aligned to industry regulations, while applying a proven systems engineering approach to product development
“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 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.”