Case Studies C2DX, Inc. Impresses Auditors and Achieves MDSAP Certification After Implementing Medical Device QMS (MDQMS)

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	C2DX, Inc. Impresses Auditors and Achieves MDSAP Certification After Implementing Medical Device QMS (MDQMS)

C2DX, Inc. Impresses Auditors and Achieves MDSAP Certification After Implementing Medical Device QMS (MDQMS)

Technology Category	Functional Applications - Enterprise Asset Management Systems (EAM) Application Infrastructure & Middleware - Data Exchange & Integration
Applicable Industries	Healthcare & Hospitals Life Sciences
Applicable Functions	Quality Assurance Business Operation
Use Cases	Regulatory Compliance Monitoring Remote Asset Management
Services	System Integration Training
Challenge	C2DX, Inc. faced the challenge of ensuring a quality-first approach after acquiring a product from Stryker. They needed to establish a robust quality management system to maintain high standards, continue delivering a high-quality device, and provide the same customer experience that Stryker's customers had come to expect. Additionally, they aimed to implement an electronic quality management system (eQMS) that could support both their immediate needs and future growth. Read More
About Customer	C2DX, Inc. is a medical device company headquartered in Schoolcraft, MI. The company specializes in diagnostic tools for monitoring compartmental pressure, particularly the STIC Intra-Compartmental Pressure Monitor System, which has been the Gold Standard for over 30 years. The team at C2DX, Inc. is composed of experienced professionals from the medical device industry, including Kevin McLeod, CEO, Amy Papranec, VP of Operations, Rick Huyser, VP of Engineering, and Ryan Eggleston, Director of Quality & Regulatory. The company values quality as the backbone of their organization and aims to deliver high-quality products while ensuring customer satisfaction. Read More
Solution	C2DX, Inc. decided to implement Greenlight Guru's medical device QMS (MDQMS) to establish a solid foundation for quality management. The decision was influenced by the team's prior experiences with manual processes and the need for a scalable, electronic solution. The implementation process was quick and intuitive, taking less than 30 days to set up an audit-ready system. The MDQMS facilitated various quality management activities, including document management, post-market quality event workflows, and design transfers to contract manufacturers. The system also made training and onboarding new hires easier, contributing to the company's overall efficiency and readiness for audits. Read More Log in to view content
Contents

Technology Category

Functional Applications - Enterprise Asset Management Systems (EAM)

Application Infrastructure & Middleware - Data Exchange & Integration

Applicable Industries

Healthcare & Hospitals

Life Sciences

Applicable Functions

Quality Assurance

Business Operation

Use Cases

Regulatory Compliance Monitoring

Remote Asset Management

Services

System Integration

Training

Challenge

C2DX, Inc. faced the challenge of ensuring a quality-first approach after acquiring a product from Stryker. They needed to establish a robust quality management system to maintain high standards, continue delivering a high-quality device, and provide the same customer experience that Stryker's customers had come to expect. Additionally, they aimed to implement an electronic quality management system (eQMS) that could support both their immediate needs and future growth.

About Customer

C2DX, Inc. is a medical device company headquartered in Schoolcraft, MI. The company specializes in diagnostic tools for monitoring compartmental pressure, particularly the STIC Intra-Compartmental Pressure Monitor System, which has been the Gold Standard for over 30 years. The team at C2DX, Inc. is composed of experienced professionals from the medical device industry, including Kevin McLeod, CEO, Amy Papranec, VP of Operations, Rick Huyser, VP of Engineering, and Ryan Eggleston, Director of Quality & Regulatory. The company values quality as the backbone of their organization and aims to deliver high-quality products while ensuring customer satisfaction.

Solution

C2DX, Inc. decided to implement Greenlight Guru's medical device QMS (MDQMS) to establish a solid foundation for quality management. The decision was influenced by the team's prior experiences with manual processes and the need for a scalable, electronic solution. The implementation process was quick and intuitive, taking less than 30 days to set up an audit-ready system. The MDQMS facilitated various quality management activities, including document management, post-market quality event workflows, and design transfers to contract manufacturers. The system also made training and onboarding new hires easier, contributing to the company's overall efficiency and readiness for audits.

Impact #1	The implementation of Greenlight Guru's MDQMS allowed C2DX, Inc. to streamline their quality management processes, making it easier to manage documents, revisions, and signatures.
Impact #2	The system facilitated design transfers to contract manufacturers, ensuring a smooth transition and maintaining high-quality standards.
Impact #3	Training and onboarding new hires became more efficient, thanks to the intuitive and user-friendly nature of the MDQMS.

Impact #1

The implementation of Greenlight Guru's MDQMS allowed C2DX, Inc. to streamline their quality management processes, making it easier to manage documents, revisions, and signatures.

Impact #2

The system facilitated design transfers to contract manufacturers, ensuring a smooth transition and maintaining high-quality standards.

Impact #3

Training and onboarding new hires became more efficient, thanks to the intuitive and user-friendly nature of the MDQMS.

Benefit #1	C2DX, Inc. achieved FDA approval within 30 days of implementing the MDQMS.
Benefit #2	The company successfully obtained MDSAP and ISO certifications shortly after implementing the system.

Benefit #1

C2DX, Inc. achieved FDA approval within 30 days of implementing the MDQMS.

Benefit #2

The company successfully obtained MDSAP and ISO certifications shortly after implementing the system.

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Overview

C2DX, Inc. Impresses Auditors and Achieves MDSAP Certification After Implementing Medical Device QMS (MDQMS)

Operational Impact

Quantitative Benefit