Case Studies How Delta Development Team Fast-Tracked R&D Down to a Single Year by Implementing a MDQMS

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	How Delta Development Team Fast-Tracked R&D Down to a Single Year by Implementing a MDQMS

How Delta Development Team Fast-Tracked R&D Down to a Single Year by Implementing a MDQMS

Technology Category	Application Infrastructure & Middleware - Data Exchange & Integration 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 Testing & Certification Training
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. Read More
About 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. Read More
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. Read More Log in to view content
Contents

Technology Category

Application Infrastructure & Middleware - Data Exchange & Integration

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

Testing & Certification

Training

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.

About 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.

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.

Impact #1	Greenlight Guru's MDQMS enabled Delta Development Team to automate and streamline management sign-offs on digital design reviews and other quality documentation.
Impact #2	The team built a foundation for closed-loop traceability throughout their quality system, linking design components and relevant documentation.
Impact #3	The implementation of the MDQMS allowed the team to avoid time wasted on low value-added activities and additional spend on resources while finalizing their device's design.

Impact #1

Greenlight Guru's MDQMS enabled Delta Development Team to automate and streamline management sign-offs on digital design reviews and other quality documentation.

Impact #2

The team built a foundation for closed-loop traceability throughout their quality system, linking design components and relevant documentation.

Impact #3

The implementation of the MDQMS allowed the team to avoid time wasted on low value-added activities and additional spend on resources while finalizing their device's design.

Benefit #1	Delta Development Team fast-tracked their development phase to a single year.
Benefit #2	The implementation of Greenlight Guru's MDQMS eliminated the need for dedicated personnel for quality management.

Benefit #1

Delta Development Team fast-tracked their development phase to a single year.

Benefit #2

The implementation of Greenlight Guru's MDQMS eliminated the need for dedicated personnel for quality management.

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Overview

How Delta Development Team Fast-Tracked R&D Down to a Single Year by Implementing a MDQMS

Operational Impact

Quantitative Benefit