How Priority Designs Used Greenlight Guru to Gain ISO 13485:2016 Certification
公司规模
SME
地区
- America
国家
- United States
产品
- Greenlight Guru
技术栈
- eQMS
实施规模
- Enterprise-wide Deployment
影响指标
- Customer Satisfaction
- Brand Awareness
- Digital Expertise
技术
- 应用基础设施与中间件 - 数据交换与集成
- 功能应用 - 企业资源规划系统 (ERP)
适用行业
- 医疗保健和医院
- Professional Service
适用功能
- 质量保证
- 产品研发
用例
- 监管合规监控
服务
- 系统集成
- 培训
关于客户
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.
挑战
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.
解决方案
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.
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