Fix the Mask turns to Qualio Plus to bring a medical device to market during the pandemic
Customer Company Size
SME
Region
- America
Country
- United States
Product
- Qualio Plus
- Essential Mask Brace
Tech Stack
- Cloud-based electronic quality management system (eQMS)
Implementation Scale
- Enterprise-wide Deployment
Impact Metrics
- Productivity Improvements
- Customer Satisfaction
- Digital Expertise
Technology Category
- Platform as a Service (PaaS) - Data Management Platforms
- Application Infrastructure & Middleware - API Integration & Management
- Application Infrastructure & Middleware - Data Exchange & Integration
Applicable Industries
- Healthcare & Hospitals
Applicable Functions
- Quality Assurance
- Product Research & Development
Use Cases
- Regulatory Compliance Monitoring
- Remote Collaboration
Services
- Cloud Planning, Design & Implementation Services
- System Integration
- Training
About The Customer
Fix the Mask is a medical device organization with a simple mission: helping everyone stay healthy during the pandemic by wearing well-fitting masks. The group, which is based in California, makes a brace that is worn over a surgical mask that ensures the mask stays tightly affixed to the individual’s face so that germs don’t get through. The organization was created in response to the COVID-19 pandemic and is led by CEO Sabrina Paseman. The company focuses on providing a solution to the problem of loose-fitting masks, which can allow virus droplets to spread. Their flagship product, the Essential Mask Brace, aims to give everyone an N95 fit.
The Challenge
Fix the Mask was created in response to the COVID-19 pandemic. As the virus began shutting everything down, people around the world started scrambling to get masks to protect themselves and their communities. Unfortunately, many of these masks were loose-fitting, which gave virus droplets a path to potentially spread. Seeking a way to give everyone an N95 fit, Sabrina Paseman, CEO of Fix the Mask, and her sister, Katherine, put their brains together and invented the Essential Mask Brace, the nonprofit’s flagship product. As they began trying to bring the product to market, Paseman quickly realized how difficult it was to check every box and get the FDA’s blessing.
The Solution
Since time was of the essence, Paseman couldn’t afford to wait any longer than was absolutely necessary to get the mask brace to market. So, she began searching for a quality management system (QMS) that would make the process of securing FDA approval much easier. After doing her due diligence and exploring her options, Paseman ultimately decided that Qualio, the cloud-based electronic quality management system for life sciences companies, was the best fit for her nonprofit’s needs. As someone new to FDA approval processes, Paseman opted to go a step further by investing in Qualio Plus, Qualio’s quality as a service offering that couples the company’s powerful eQMS with expert Quality Assurance support.
Operational Impact
Quantitative Benefit
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