CVRx® manages risk and accelerates time-to-market with PTC integrity
公司规模
11-200
地区
- America
国家
- United States
产品
- PTC Integrity
- XR-1 System
技术栈
- IBM Rational DOORS
- Microsoft Word
实施规模
- Enterprise-wide Deployment
影响指标
- Cost Savings
- Productivity Improvements
技术
- 应用基础设施与中间件 - API 集成与管理
适用行业
- 医疗保健和医院
适用功能
- 产品研发
- 质量保证
用例
- 预测性维护
- 远程资产管理
服务
- 软件设计与工程服务
- 系统集成
关于客户
CVRx is a privately held medical device company based in Minneapolis, Minnesota. The company has developed proprietary active implantable technology for the treatment of high blood pressure and heart failure. As a venture capital-funded company, CVRx must move its development projects quickly to clinical trials without sacrificing quality due to long regulatory approval cycles. The company is developing a second-generation system, XR-1, to provide Baroreflex Activation Therapy. The XR-1 System is a Class III medical device, indicating it could support or lengthen human life, prevent a serious health issue, or potentially pose a significant health risk if not properly evaluated. The system is subject to the most stringent FDA regulation and is subject to premarket approval.
挑战
CVRx, a medical device company, was developing a second-generation system, XR-1, for Baroreflex Activation Therapy. The company initially used IBM Rational DOORS as the requirements management engineering platform. However, after a year, CVRx needed a more flexible, configurable, and customizable platform that could also facilitate requirements reuse. As the project evolved, the company recognized a need for a broader toolset capable of more than just requirements management. To meet compliance regulations and ensure quality while maintaining an aggressive schedule, CVRx needed a comprehensive solution that could manage its requirements, specifications, test cases, change requests, defects, and other documents, processes, and records, as well as automate compliance reporting.
解决方案
CVRx selected PTC Integrity as its engineering documentation and development platform. PTC Integrity provided the flexibility, configurability, and customizability that CVRx needed. It also facilitated requirements reuse and provided a broader toolset than just requirements management. PTC Integrity could manage CVRx's requirements, specifications, test cases, change requests, defects, and other documents, processes, and records, and automate compliance reporting. The platform also provided traceability between disciplines, which is necessary for effectively managing risk. In 2008, CVRx replaced IBM Rational DOORS with PTC Integrity for requirements management. The scope of PTC Integrity was broadened to include source code management, with ties to tasks and workflow management between requirements and source code. Risk management, development issue management, and standards requirements capabilities were added to the platform.
运营影响
数量效益
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