How Innovere Accelerated Their Path to Market by Implementing an Eqms Purpose Built for Medical Device Companies
公司规模
SME
地区
- America
国家
- Canada
- United States
产品
- Greenlight Guru
- Innovision™
技术栈
- Cloud-based QMS
- ISO 13485 Compliance
实施规模
- Enterprise-wide Deployment
影响指标
- Customer Satisfaction
- Digital Expertise
- Productivity Improvements
技术
- 功能应用 - 企业资源规划系统 (ERP)
- 功能应用 - 远程监控系统
适用行业
- 医疗保健和医院
适用功能
- 质量保证
- 产品研发
用例
- 预测性维护
- 监管合规监控
- 远程资产管理
服务
- 系统集成
- 云规划/设计/实施服务
- 培训
关于客户
Innovere is a company based in Markham, Ontario, Canada, focused on improving the patient experience associated with MRI technology. Their Innovision™ device aims to provide visual entertainment and advanced sound quality to increase overall comfort during an MRI. The company faced challenges due to their lack of in-house medical device expertise, which hindered their ability to establish a compliant Quality Management System (QMS). They were determined to find a QMS partner that could enhance their team’s industry knowledge and accelerate their path to commercialization.
挑战
Innovere faced significant challenges in establishing a compliant Quality Management System (QMS) due to their lack of in-house medical device expertise. This was crucial for scaling their product development efforts efficiently. They needed a QMS partner to enhance their industry knowledge and accelerate their path to commercialization. Additionally, they found that many companies were using paper-based systems, which they deemed inefficient and unsuitable for their needs.
解决方案
Innovere chose Greenlight Guru as their QMS partner. The implementation process was quick and efficient, allowing Innovere to take full advantage of the software within a few weeks. Greenlight Guru provided one-on-one sessions with their Customer Success Team, equipping Innovere with the necessary knowledge to leverage the software for design control and risk management activities. The software's built-in controls and traceability features were particularly beneficial during their first audit by a potential partner's Supplier Quality Department. The audit was seamless and paperless, thanks to Greenlight Guru's fully connected medical device quality management software. This successful audit led to a commercial partnership agreement for Innovere.
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