F2 Labs: Making the World a Safer Place, One Device at a Time
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After graduating with her electrical engineering degree from the University of Maryland in 1989, Wendy Fuster wasn’t initially seeking to start an electromagnetic compatibility (EMC) and Safety testing lab. “When I graduated, I joined my husband Oscar’s computer manufacturing firm. Soon after joining, the firm shifted from being a reseller to self-branded systems integrator. The transition demanded numerous new regulatory approvals, which became my responsibility but with which I had no experience.”
What followed was a frustrating and time-consuming effort to find a testing lab to help Wendy with the regulatory approval process, which was crucial in order to get their product to market. Ultimately, Wendy found that the labs she consulted with took too long to provide quotes and complete their work, and moreover, provided little to no guidance as to how the process worked. “Ultimately, I am so glad we went through that experience, because I will never forget the feeling of being unable to find a real partner,” Wendy recounts. In discussing the issues she’d encountered with Oscar, her husband challenged Wendy to up-end the status quo by setting up her own in-house testing site. When Oscar’s firm went public, Oscar and Wendy retained F2 Labs, which now caters to the compliance testing needs of numerous medical and other equipment manufacturers domestically and globally.
An accredited regulatory testing laboratory with more than 25 years of experience in performing EMC and Safety evaluations, F2 emphasizes efficient testing operations, exceptional customer service, and quality testing focused on attention to detail. As Wendy reiterates, “F2’s vision is to maintain a customer-driven culture. We go out of our way to assist our clients through the entire process, from the very first consultation with our sales team, to delivery of a final report to the client and beyond.”
Over the years, F2 has worked with many companies struggling to get their products approved by the FDA and other regulatory authorities, mostly due to failed compliance with standards. “Even after receiving feedback from the FDA following an initial submission, customers often struggle to understand the reviewer’s comments and non-conformances issued, because the content can be confusing and ambiguous, ” Wendy explains. “We’ve helped clients who came to us after prior testing performed by other labs led to FDA failures, and guided them through the process of interpreting and responding to the FDA to achieve a passing result.”
Our objective is not to simply be a vendor or service provider, but a true partner to our clients
Further, with the ever-increasing adoption of wireless technology in medical devices, regulators demand new and additional testing that most manufacturers are not familiar with—F2 was the first lab in the country to offer AIM 7351731 RFID Immunity testing. The company not only stays apprised of the latest trends by attending FDA conferences and continuously training its engineers, but also communicates directly with its contacts at regulatory agencies to guide customers to approval—and as a result, to market—as quickly as possible.
Approach to Testing: Partnering with the Customer
Whether a customer approaches F2 before or after their initial FDA submission, F2 always works hand-in-hand with the client to examine and learn about the device and all of its capabilities. For products that have already undergone an initial FDA examination, the company also takes great care to scrutinize any comments provided by the FDA. Most importantly, F2 consults directly with its customers from day one and maintains an open line of communication to comprehend their needs.
F2’s customer driven culture, combined with its unparalleled knowledge of FDA regulations and requirements, allows F2 to exceed its customers’ expectations by not only helping them achieve regulatory compliance, but to understand what is required and why. As Wendy puts it, “Our culture is to be customer first. We go out of our way to assist our clients through the entire process, and our objective is not to simply be a vendor or service provider, but a true partner to our clients.”
F2’s Bright Future
F2 has grown steadily since its inception, both in terms of its client base and the scope of testing it can provide. This year the company added a 10-meter anechoic chamber and increased lab space in its Ohio facility. F2 continues to expand the services it offers, including additional consulting services for customers who are not ready for “actual” testing, but want to stay ahead of the game. “I am so proud of our F2 Labs family,” Wendy emphasizes, “Andy, our VP, and Ken, our Director of EMC and Wireless, work tirelessly to make us the best testing lab around, and continue to develop new services and processes that consistently exceed our customers’ expectations. F2 is working on new and exciting things. Stay tuned!”
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