Case Studies How Priority Designs Used Greenlight Guru to Gain ISO 13485:2016 Certification

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	How Priority Designs Used Greenlight Guru to Gain ISO 13485:2016 Certification

How Priority Designs Used Greenlight Guru to Gain ISO 13485:2016 Certification

Technology Category	Application Infrastructure & Middleware - Data Exchange & Integration Functional Applications - Enterprise Resource Planning Systems (ERP)
Applicable Industries	Healthcare & Hospitals Professional Service
Applicable Functions	Product Research & Development Quality Assurance
Use Cases	Regulatory Compliance Monitoring
Services	System Integration Training
Challenge	Priority Designs, an industrial design consulting firm, faced a significant challenge in securing more advanced medical device design projects. Despite their extensive experience in product design across various industries, they lacked the necessary ISO certifications and a compliant quality management system (QMS) to take a product through the full process and turn it over to manufacturing. Potential customers frequently inquired about their ISO certifications and quality system, but Priority Designs had to decline these opportunities due to their lack of compliance. This gap in their capabilities prompted the team to seek a solution that would enable them to win more design work in the medical device sector. They needed a structured quality system to store records and create a design history file (DHF), as they were not recording their activities or aware of the regulations around record-keeping for medical device design. The search for a suitable QMS led them to discover Greenlight Guru, an eQMS system purpose-built for medical device companies. Read More
About Customer	Priority Designs is a well-established industrial design consulting firm based in Columbus, Ohio, USA. Founded in 1990, the company has over 30 years of experience specializing in product development design, including research, human factors, strategy, prototyping, and brand development. With a team of about 65 employees, Priority Designs has designed innovative products for renowned brands such as Nike, GE, and TaylorMade, as well as medical devices like surgical instruments and dental products. They also contributed to the early prototyping and development of the Q Collar, a medical device worn by NFL All-Pro Luke Kuechly to protect against mild traumatic brain injury. Despite not being a medical device manufacturer, Priority Designs sought to leverage Greenlight Guru to gain a competitive advantage in the medical device design market. Read More
Solution	Priority Designs implemented Greenlight Guru, an electronic Quality Management System (eQMS) specifically designed for medical device companies. The implementation was led by Donna Philput, Senior Quality/Regulatory Specialist at Priority Designs, who collaborated with the Greenlight Guru Customer Success Team for training and customization. The team purchased Greenlight Guru's audit-tested templates to expedite their ISO 13485:2016 certification process. The implementation went smoothly, with weekly training sessions to understand medical device regulations and the new quality system. Within a few months, all QMS documentation was customized, uploaded, and ready for use. The Greenlight Guru software provided an intuitive platform with excellent customer service, meeting Priority Designs' requirements for a medical device quality management system. The system allowed them to manage their QMS, control deliverables, training, and project plans, and regularly upload and keep documents current. The software's validation protocols ensured compliance with regulations, impressing auditors during internal and external audits. Read More Log in to view content
Contents

Technology Category

Application Infrastructure & Middleware - Data Exchange & Integration

Functional Applications - Enterprise Resource Planning Systems (ERP)

Applicable Industries

Healthcare & Hospitals

Professional Service

Applicable Functions

Product Research & Development

Quality Assurance

Use Cases

Regulatory Compliance Monitoring

Services

System Integration

Training

Challenge

Priority Designs, an industrial design consulting firm, faced a significant challenge in securing more advanced medical device design projects. Despite their extensive experience in product design across various industries, they lacked the necessary ISO certifications and a compliant quality management system (QMS) to take a product through the full process and turn it over to manufacturing. Potential customers frequently inquired about their ISO certifications and quality system, but Priority Designs had to decline these opportunities due to their lack of compliance. This gap in their capabilities prompted the team to seek a solution that would enable them to win more design work in the medical device sector. They needed a structured quality system to store records and create a design history file (DHF), as they were not recording their activities or aware of the regulations around record-keeping for medical device design. The search for a suitable QMS led them to discover Greenlight Guru, an eQMS system purpose-built for medical device companies.

About Customer

Priority Designs is a well-established industrial design consulting firm based in Columbus, Ohio, USA. Founded in 1990, the company has over 30 years of experience specializing in product development design, including research, human factors, strategy, prototyping, and brand development. With a team of about 65 employees, Priority Designs has designed innovative products for renowned brands such as Nike, GE, and TaylorMade, as well as medical devices like surgical instruments and dental products. They also contributed to the early prototyping and development of the Q Collar, a medical device worn by NFL All-Pro Luke Kuechly to protect against mild traumatic brain injury. Despite not being a medical device manufacturer, Priority Designs sought to leverage Greenlight Guru to gain a competitive advantage in the medical device design market.

Solution

Priority Designs implemented Greenlight Guru, an electronic Quality Management System (eQMS) specifically designed for medical device companies. The implementation was led by Donna Philput, Senior Quality/Regulatory Specialist at Priority Designs, who collaborated with the Greenlight Guru Customer Success Team for training and customization. The team purchased Greenlight Guru's audit-tested templates to expedite their ISO 13485:2016 certification process. The implementation went smoothly, with weekly training sessions to understand medical device regulations and the new quality system. Within a few months, all QMS documentation was customized, uploaded, and ready for use. The Greenlight Guru software provided an intuitive platform with excellent customer service, meeting Priority Designs' requirements for a medical device quality management system. The system allowed them to manage their QMS, control deliverables, training, and project plans, and regularly upload and keep documents current. The software's validation protocols ensured compliance with regulations, impressing auditors during internal and external audits.

Impact #1	Priority Designs successfully conducted internal audits and ran projects through Greenlight Guru to understand the platform's functionality and verify their processes.
Impact #2	The Greenlight Guru Customer Success Team provided on-site support to help Priority Designs prepare for their first audit, ensuring they understood audit requirements and priorities.
Impact #3	During audits, Priority Designs could easily locate and provide required documents, demonstrating a clear document trail and compliance with regulations.

Impact #1

Priority Designs successfully conducted internal audits and ran projects through Greenlight Guru to understand the platform's functionality and verify their processes.

Impact #2

The Greenlight Guru Customer Success Team provided on-site support to help Priority Designs prepare for their first audit, ensuring they understood audit requirements and priorities.

Impact #3

During audits, Priority Designs could easily locate and provide required documents, demonstrating a clear document trail and compliance with regulations.

Benefit #1	Priority Designs achieved ISO 13485:2016 certification within a year of implementing Greenlight Guru.
Benefit #2	The implementation of Greenlight Guru allowed Priority Designs to quickly customize and upload all QMS documentation within a few months.

Benefit #1

Priority Designs achieved ISO 13485:2016 certification within a year of implementing Greenlight Guru.

Benefit #2

The implementation of Greenlight Guru allowed Priority Designs to quickly customize and upload all QMS documentation within a few months.

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Overview

How Priority Designs Used Greenlight Guru to Gain ISO 13485:2016 Certification

Operational Impact

Quantitative Benefit