What sets inventors apart from entrepreneurs is the practicality of their idea. A new product or business that will have immediate demand upon launch is one that’s destined for success. The niche that Tracy Eberly found for Fang Consulting, which manages regulatory affairs, quality assurance and need fulfillment for medical device companies, is not easily replicated. That’s why his Minnesota-based company, which he has been the owner of for more than two decades, continues to thrive. Workers from the medical device sector who are looking to learn more about Tracy Eberly — and the customizable services his firm offers — have come to the right place.
A graduate of the University of Minnesota, Mr. Eberly has held numerous roles in the medical sector. His duties have included meeting U.S. Food and Drug Administration needs, quality assurance, regulatory affairs, overseeing cost-reduction efforts and technical file remediation for specific medical products. Many of these paths have come to converge at Fang Consulting, where Tracy Eberly is the CEO. The company provides daily regulatory and quality assistance as well as European Union Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) analysis and remediation. The significance of these two overseas rules can’t be understated. A medical device company looking to get its products out to additional users must adhere to often complex expectations; Tracy Eberly and Fang Consulting help make that happen.
The coronavirus pandemic has had a profound impact on so many facets of our daily lives — medical devices and future approvals are certainly among them. That’s why Tracy Eberly and the rest of Fang Consulting have worked hard to draft policies and procedures that their clients can adopt. Not only will these best practices help clients stay open, but they have also been designed to meet HIPPA, OSHA and ADA compliance while keeping employees and customers safe. June 2020 financing deals for the U.S. medical devices industry alone was valued at $645 million, according to MedicalDevice-Network.com. This staggering total goes to show the importance of this sector and high stakes at play when it comes to approvals and distribution deals.
When working with Mr. Eberly and the rest of his team, clients will benefit from quality management plans meant to guarantee device compliance. This is an extraordinarily important benchmark when the rules vary on a global scale and international authorities all have individual expectations. This guidance from experts – Tracy Eberly included – will give medical device firms the crucial guidance needed to compete with other manufacturers while also providing the very best products.