How Delta Development Team Fast-Tracked R&D Down to a Single Year by Implementing a MDQMS
Customer Company Size
SME
Region
- America
Country
- United States
Product
- Greenlight Guru MDQMS
Tech Stack
- MDQMS software
- Google Suite
Implementation Scale
- Enterprise-wide Deployment
Impact Metrics
- Productivity Improvements
- Customer Satisfaction
- Digital Expertise
Technology Category
- Functional Applications - Enterprise Asset Management Systems (EAM)
- Functional Applications - Enterprise Resource Planning Systems (ERP)
Applicable Industries
- Healthcare & Hospitals
- National Security & Defense
Applicable Functions
- Product Research & Development
- Quality Assurance
Use Cases
- Predictive Maintenance
- Regulatory Compliance Monitoring
- Remote Asset Management
Services
- System Integration
- Training
- Testing & Certification
About The Customer
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.
The Challenge
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.
The Solution
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.
Operational Impact
Quantitative Benefit
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