Fix the Mask turns to Qualio Plus to bring a medical device to market during the pandemic
公司规模
11-200
地区
- America
国家
- United States
产品
- Qualio Plus
- Essential Mask Brace
技术栈
- Cloud-based electronic quality management system (eQMS)
实施规模
- Enterprise-wide Deployment
影响指标
- Customer Satisfaction
- Digital Expertise
- Productivity Improvements
技术
- 应用基础设施与中间件 - API 集成与管理
- 应用基础设施与中间件 - 数据交换与集成
- 平台即服务 (PaaS) - 数据管理平台
适用行业
- 医疗保健和医院
适用功能
- 产品研发
- 质量保证
用例
- 监管合规监控
- 远程协作
服务
- 云规划/设计/实施服务
- 系统集成
- 培训
关于客户
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.
挑战
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.
解决方案
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.
运营影响
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