How Solius Replaced Paper with Eqms to Gain ISO 13485:2016 Certification in Weeks
公司规模
11-200
地区
- America
国家
- Canada
- United States
产品
- Greenlight Guru
技术栈
- Cloud-based QMS
实施规模
- Enterprise-wide Deployment
影响指标
- Customer Satisfaction
- Digital Expertise
- Productivity Improvements
技术
- 功能应用 - 计算机化维护管理系统 (CMMS)
- 功能应用 - 企业资源规划系统 (ERP)
适用行业
- 医疗保健和医院
- 生命科学
适用功能
- 商业运营
- 质量保证
用例
- 监管合规监控
服务
- 系统集成
- 培训
关于客户
SOLIUS was founded by a duo seven years ago, but their product development efforts have ramped up in the past several years. Their device is a Class II phototherapy device that bridges a medical device and a wellness device that stimulates the body to produce Vitamin D–something the body is already meant to do. SOLIUS’ device is the first of its kind in terms of its labeling and conditions for use. This makes their pathway to market a bit more unique and may present some challenges. Their goal is to successfully bring their device to market with its current labeling with Health Canada, then meet with the FDA to assess how the device will be received.
挑战
The vision at SOLIUS was to bring the product to market as a medical device, meaning that their team was aware of the quality management regulations they would have to comply with. With four team members at the time, managing compliance and a QMS was an immediate hurdle they needed to overcome. They began to vet solutions that would help them manage the regulatory and quality requirements of their target markets, without them becoming overwhelmed with compliance efforts. They began searching for a solution that was cloud-based, secure, affordable, scalable, and came with advice from industry experts that could guide them along the way.
解决方案
No one on the SOLIUS team had any expertise in medical device quality management at the time, leaving them thoroughly impressed by the talent and experience onboard at Greenlight Guru. These industry experts gave the team at SOLIUS the confidence in what they were doing with the software and industry knowledge. When it came down to making a decision, SOLIUS went with Greenlight Guru due to the stability of the company, impressive talent industry gurus onboard, and the stability of Greenlight Guru as a company. Linda Cox, Senior VP, QA/RA/Clinical Initiative at SOLIUS, assessed the cost of Greenlight Guru and decided that it was well worth it. Along with the software, they found immense value in the on-boarding process, knowledge base, and QMS templates. It was Greenlight Guru’s Customer Success Team that played a paramount role, providing guidance and mentorship during their earlier days. SOLIUS’ CTO worked with Greenlight Guru to get the software up and running, and found that the team was excellent in helping them get the system in place. It took them a few months to transfer all of their data into the system, due to initial hesitancy that they would make mistakes. Once they transferred over their data, they realized that there was really no way for them to mess it up. The team at SOLIUS worked with Greenlight Guru’s Customer Success Team on adopting the product and ensuring that their processes were sound. The guidance provided by Greenlight Guru reassured SOLIUS that they had made the right decision.
运营影响
数量效益
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