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Welwaze meets ISO: A Promise of Quality

Bat appreciation month, celebrating the bilingual child month, and American cheese month… Although seemingly random, all of these trifling causes share the month of October with a much more notable cause: Breast Cancer Awareness Month.

As the second most commonly diagnosed cancer among American women, about 1 in 8 U.S. women will develop invasive breast cancer over the course of their life. Luckily, though still high, the overall death rate from breast cancer has slowly decreased as a result of treatment advances and earlier detection through increased awareness and screening.

In aid of this cause, Welwaze Medical, a purpose driven company founded in Miami, has taken it upon the vision of their founders to “empower women around the world to take control of their breast health”. With their innovative product, CELBREA® (www.celbrea.com), Welwaze offers an immediate and easy-to-interpret method of finding potential underlying breast pathologies, including breast cancer.

Looking to offer only the best product, Welwaze made a couple of strategic moves. The first one was to implement a quality management system (QMS) based on ISO 13485 standards (QMS for Medical Devices), and the second one was selecting EPIC Consultants Inc. (EPIC) to help Welwaze establish, document, implement and sustain the QMS.

With the QMS in effect for the past year, we bring Welwaze’s experiences and insights as shared by Michelle Cuccia, Welwaze’s Chief Business Officer.

“Our motivation to implement a quality management system came when our company shifted from an operational mindset to a customer centric, quality before anything, mindset, as we prepared to go-to-market.”

Initially looking to fulfill regulatory requirements and obtaining their “passport to the world,” Welwaze also saw this as an opportunity to ensure that quality would be at the forefront of their business model. By implementing the ISO 13485 system, Welwaze would be holding itself, and its product, accountable for working safely and effectively – all the time.

“The entire process has been very challenging especially because we are a startup organization… when we first started down this road, we were still perfecting our product and our entire operation. Having EPIC come in with the GMP and ISO know-how that we didn’t have in house was incredibly valuable.”

Through this journey, Welwaze was constantly training its employees on new SOPs to better equip its staff to consistently meet the goals and objectives they established in their Quality Policy. The QMS constantly pushes the company to spend more time in the trenches with its processes and to analyze the feedback from its clients and patients. This allows for a better understanding of where the opportunities lie with the ultimate goal of continuous improvement and total customer satisfaction. For Welwaze, one of these opportunities came in the form of production waste. After a year of their QMS implementation, Welwaze has seen a 57% decrease in production waste from non-conforming products and are now looking to set that goal even higher!

       57% decrease in production waste?     Congratulations to Welwaze's team!

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“EPIC was truly our right hand and guide through all of this. They were great teachers and were instrumental in helping us become self-sufficient.”

“One of the coolest parts of this Welwaze journey is the fact that they’re a start up!” said Luiz Nery, a senior consultant with EPIC. “Implementing ISO 13485 so early in their lifespan greatly influenced the way they manage risk by defining where they should focus their efforts in the development of their company, pointing them in the right direction early on, saving them a lot of time and money.”

Clearly, implementing an ISO Quality Management System can meet a lot more than a regulatory checkbox. According to a study done by the American Society for Quality, as a guide, “for every 1 dollar you spend on your quality management system, you can expect to receive 6 dollars back in revenue.” What other investment has that kind of ROI?

EPIC is proud to have played a role in Welwaze’s QMS implementation and to be always here to make it better, together.

References

1. American Cancer Society. How Common Is Breast Cancer? Jan. 2020. Available at: https://www.cancer.org/cancer/breast-cancer/about/how-common-is-breast-cancer.html.

2. ISOUpdate. What’s the Return on Investment (ROI) on Quality? Apr. 2018. Available at: https://isoupdate.com/resources/whats-roi-quality/