How Delta Development Team Fast-Tracked R&D Down to a Single Year by Implementing a MDQMS
公司规模
SME
地区
- America
国家
- United States
产品
- Greenlight Guru MDQMS
技术栈
- MDQMS software
- Google Suite
实施规模
- Enterprise-wide Deployment
影响指标
- Productivity Improvements
- Customer Satisfaction
- Digital Expertise
技术
- 功能应用 - 企业资产管理系统 (EAM)
- 功能应用 - 企业资源规划系统 (ERP)
适用行业
- 医疗保健和医院
- 国家安全与国防
适用功能
- 产品研发
- 质量保证
用例
- 预测性维护
- 监管合规监控
- 远程资产管理
服务
- 系统集成
- 培训
- 测试与认证
关于客户
Delta Development Team, headquartered in Tucson, AZ, specializes in designing critical devices for military and emergency applications. The company is led by CTO Robert Futch and CEO Monti Leija, a retired Army veteran. They focus on creating innovative solutions that meet stringent military and regulatory requirements. Their target markets include the USA, specifically the FDA and the U.S. Department of Defense. The team is committed to maintaining high standards of quality and speed in bringing their products to market.
挑战
Delta Development Team faced the challenge of developing a portable refrigeration unit for extreme military applications. They needed to navigate complex military requirements and regulatory guidelines for medical devices. The team sought a solution that would allow them to maintain control over product development, manufacturing, and regulatory processes to ensure speed to market. Initial attempts with tools like Google Suite proved insufficient for their needs, prompting them to seek a more robust, automated quality management system.
解决方案
Delta Development Team chose Greenlight Guru's medical device QMS (MDQMS) to address their quality management needs. The MDQMS software provided a database-like architecture with high levels of automation, supporting linkages between different points in the device's design and quality system. This enabled the team to achieve traceability and efficiency, crucial for performing well in audits. The implementation included audit-tested QMS templates and consultory services from Greenlight Guru, which streamlined the process and provided regulatory guidance. The software's intuitive flow allowed the team to quickly get up and running, automating quality management and achieving closed-loop traceability.
运营影响
数量效益
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