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Dechoker’s overwhelming success drives full compliance to FDA requirements.

October 18, 2021

Dechoker’s overwhelming success drives full compliance to FDA requirements.

It’s no surprise that Dechoker’s revolutionary airway clearing device is getting attention. As sales have ramped up so have reported life saves from its device. In the past weekend, the Dechoker team was a buzz with 6 new life saves coming in just three days. Dechoker’s Vice President Sean Pittman says “Saving lives is an important thing, it's not every day you get to be a part of that.” But the work of creating a life-saving device is an arduous one and something the entire Dechoker team is dedicated to.

Creating an invention, something that has not been done before comes with a lot of hurdles especially when it is one that is regulated by the FDA. Throughout Dechoker’s history, the process and development of the device have gone through many stages, many of the early ones were just trying to get a device that had an advantage and was effective in the first aid protocol of a choking victim. There were many setbacks along the way but each step backward helped the company move forward with a better, safer, and more effective product. CEO Alan Carver says his goals remain the same, “Continuous improvement to provide a safe and effective device that helps eradicate choking deaths.”

 

Dechoker’s FDA Response

Dechoker is proud to be a homegrown independent medical device manufacturing company in Denver, Colorado. With the independent mindset came some learning curves in how to manufacture a device that is regulated by the FDA. Thankfully the FDA has helped Dechoker with our processes and we consider their input a vital piece to Dechoker’s future success..

Throughout this process, Dechoker has focused on bringing on first-class quality management engineers and design engineers to document, manage and drive strict adherence to FDA protocols. With the help of this talented team, we have cleared all recommendations set forth by the FDA with regards to our Quality Management Systems. Upon submitting all final remedial paperwork and documentation Dechoker has had positive conversations with the head of the FDA compliance on the next steps for the Dechoker device.

 

Dedicated Medical Board

Dechoker knows it is imperative to have a dedicated medical board that drives fundamental medical recommendations for the Dechoker device. Our global medical board consists of five doctors with each one having unique medical credentials and all of them contributing to the success of our medical device, the Dechoker. In addition to being backed bypublished clinical studies, our medical board provides a strong recommendation for the Dechoker device.

 

Dechoker’s Move Toward MDSAP and Global Markets

The next step in Dechoker’s journey is obtaining the Medical Device Single Audit Program (MDSAP) this is a program that allows a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions. The MDSAP is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States. Dechoker’s team has all the necessary documentation in place for this and expects a decision on this big step by the end of the year.


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