How Innovere Accelerated Their Path to Market by Implementing an Eqms Purpose Built for Medical Device Companies
Customer Company Size
SME
Region
- America
Country
- Canada
- United States
Product
- Greenlight Guru
- Innovision™
Tech Stack
- Cloud-based QMS
- ISO 13485 Compliance
Implementation Scale
- Enterprise-wide Deployment
Impact Metrics
- Customer Satisfaction
- Digital Expertise
- Productivity Improvements
Technology Category
- Functional Applications - Enterprise Resource Planning Systems (ERP)
- Functional Applications - Remote Monitoring & Control Systems
Applicable Industries
- Healthcare & Hospitals
Applicable Functions
- Quality Assurance
- Product Research & Development
Use Cases
- Predictive Maintenance
- Regulatory Compliance Monitoring
- Remote Asset Management
Services
- System Integration
- Cloud Planning, Design & Implementation Services
- Training
About The Customer
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.
The Challenge
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.
The Solution
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.
Operational Impact
Quantitative Benefit
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