Fix The Mask uses Qualio+ to market a medical device in record time mid-pandemic
Fix The Mask is a medical device organization with a simple mission: to help everyone stay healthy during the COVID-19 pandemic by wearing properly-fitted masks.
The Californian business produces a rubber brace, worn over a surgical mask, that keeps the mask tightly affixed to the individual’s face and prevents pathogen transmission.
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 for masks to protect themselves and their communities. Unfortunately, many of these masks were loose-fitting, which gave virus -transmitting droplets the chance to continue spreading.
Seeking a way to give everyone a healthier mask fit, Sabrina Paseman and her sister Katherine invented the Essential Mask Brace, the nonprofit’s flagship product.
But as they began trying to bring the product to market, Sabrina quickly realized how difficult it was to check every regulatory box and get the FDA’s blessing.
Sabrina couldn’t afford to wait any longer than was absolutely necessary to get her mask brace to market. She began searching for an electronic quality management system (eQMS) that would accelerate the process of securing FDA approval and ISO 13485 accreditation.
After doing her due diligence and exploring her options, Sabrina ultimately decided that Qualio was the best fit for her needs.
But as someone without a dedicated quality background new to FDA approval processes, Sabrina opted to go a step further by investing in Qualio+, Qualio’s quality-as-a-service offering that couples powerful eQMS software with targeted quality and regulatory support.
Recognizing that there were a lot of regulatory hurdles that needed to be done well, and correctly, the first time made me realize I needed some outside help.
Qualio+ delivered on its promise, allowing Sabrina and Fix The Mask to bring their medical device to market quickly in an environment where every minute mattered.
Sabrina noted a string of benefits from becoming a Qualio+ customer, including:
1. A purpose-built QMS
Before Qualio, Fix The Mask didn’t have any type of quality management system in place. Thanks to expert support and guidance from the Qualio+ team, Fix The Mask could quickly build and leverage a QMS that met their exact specifications - all hosted on a cloud-based, 'easy-to-use and intuitive' software platform.
2. Seamless onboarding
With the friendly, approachable Qualio+ team holding weekly check-ins, Sabrina felt 'incredibly supported' during her onboarding process, which ran smoothly from beginning to end and allowed the Fix The Mask team to begin using Qualio in a matter of weeks.
Qualio has created my QMS and really guided me along the way to make sure I’m hitting all the requirements.
I was genuinely impressed by the Qualio+ team. Not only was everyone very professional, they really went above and beyond to help me understand the more difficult concepts you need to know when building a QMS from scratch.
3. Streamlined processes
Qualio’s expert guidance enabled Fix The Mask to implement smart and efficient processes that made it easy to embed FDA and ISO compliance.
Sabrina noted that Fix The Mask went from having no established processes pre-Qualio to having a set of defined, 'clear and intuitive' processes followed by everyone in the business.
4. A supportive partnership
Sabrina found the Qualio+ team to be a supportive high-touch partner committed to her and her company’s success.
The Qualio+ team recognized that Sabrina was new to quality management and was able to guide her and her team in a structured and instructive way, from quality management fundamentals to in-depth software training.
Qualio+ allowed Fix The Mask to couple their new software system with detailed expertise and understanding, positioning the organization for regulatory approval and long-term market success.
If I'd tried to figure it out on my own, I would have been too overwhelmed and confused.
The Qualio+ team really cares about the success of the companies they work with.
If you’re ready to do it right the first time, it’s an excellent program.
