Case Studies Fix the Mask turns to Qualio Plus to bring a medical device to market during the pandemic

Edit This Case Study Record

	Fix the Mask turns to Qualio Plus to bring a medical device to market during the pandemic

Fix the Mask turns to Qualio Plus to bring a medical device to market during the pandemic

Technology Category	Application Infrastructure & Middleware - API Integration & Management Application Infrastructure & Middleware - Data Exchange & Integration Platform as a Service (PaaS) - Data Management Platforms
Applicable Industries	Healthcare & Hospitals
Applicable Functions	Product Research & Development Quality Assurance
Use Cases	Regulatory Compliance Monitoring Remote Collaboration
Services	Cloud Planning, Design & Implementation Services System Integration Training
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. Read More
About 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. Read More
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. Read More Log in to view content
Contents

Technology Category

Application Infrastructure & Middleware - API Integration & Management

Application Infrastructure & Middleware - Data Exchange & Integration

Platform as a Service (PaaS) - Data Management Platforms

Applicable Industries

Healthcare & Hospitals

Applicable Functions

Product Research & Development

Quality Assurance

Use Cases

Regulatory Compliance Monitoring

Remote Collaboration

Services

Cloud Planning, Design & Implementation Services

System Integration

Training

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.

About 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.

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.

Impact #1	A Purpose-Built QMS: Before Qualio, Fix the Mask didn’t have any type of QMS in place. Thanks to expert support from the Qualio team, the decision to trust Qualio Plus for quality management enabled the med device company to create a QMS that met their exact specifications.
Impact #2	Seamless Onboarding: With the friendly, approachable Qualio Plus team holding weekly check-ins to see how things were going, Paseman felt 'incredibly supported' during onboarding, which was as smooth as could be.
Impact #3	Streamlined Processes: Qualio’s expert guidance enabled Fix the Mask to implement smart and efficient processes that made it easy to ensure compliance.

Impact #1

A Purpose-Built QMS: Before Qualio, Fix the Mask didn’t have any type of QMS in place. Thanks to expert support from the Qualio team, the decision to trust Qualio Plus for quality management enabled the med device company to create a QMS that met their exact specifications.

Impact #2

Seamless Onboarding: With the friendly, approachable Qualio Plus team holding weekly check-ins to see how things were going, Paseman felt 'incredibly supported' during onboarding, which was as smooth as could be.

Impact #3

Streamlined Processes: Qualio’s expert guidance enabled Fix the Mask to implement smart and efficient processes that made it easy to ensure compliance.

Benefit #1	Targeted regulatory submission: 510(k) certification, ISO 13485: 2016, FDA 21 CFR 820, ISO 14971:2019, NIOSH 42 CFR Part 84

Benefit #1

Targeted regulatory submission: 510(k) certification, ISO 13485: 2016, FDA 21 CFR 820, ISO 14971:2019, NIOSH 42 CFR Part 84

Download PDF Version

Overview

Fix the Mask turns to Qualio Plus to bring a medical device to market during the pandemic

Operational Impact

Quantitative Benefit