Reading time ( words)
Tempe, Ariz.—Three-Five Systems (TFS) announces that it has named Leslie Honda to the newly created post of regulatory affairs director.
Honda most recently served as the VP of quality and regulatory for ClearMedical Inc., a Bellevue, Wash.-based reprocessor of single-use Class I and Class II medical devices. In that role, Honda oversaw the company's regulatory activities, including FDA and ISO interaction. She successfully led ClearMedical through the company's ISO 13485 and ISO 9001 certification processes. Prior to ClearMedical, Honda held a variety of positions with Plexus, an EMS company in Bothell, Wash. She held a variety of positions throughout her ten years with Plexus, most recently as quality assurance and regulatory affairs director, in which she drove the company's quality and medical regulatory compliance initiatives at the company's new product introduction and PCB facility in Bothell.
At TFS, Honda's initial focus will be on securing the company's Class III, or life-critical, medical device manufacturing certification during the fourth quarter of 2004. The Class III market has been identified by TFS as a key growth area for its Redmond, Wash. operation. Efforts to secure the certification began earlier in 2004 as the company sought to expand upon its history of a variety of non-life-critical medical devices for OEMs. Class III certification would place the company among a limited group of about 30 companies in the U.S. currently certified to manufacture life-critical devices for OEMs.
Van Potter, senior VP of EMS at TFS, says, "The medical device manufacturing market is a key area we have identified to deliver significant value to our customers. We have a history of producing a variety of medical OEM products, such as defibrillators, as well as sub-assemblies for medical OEM products, such as glucometers. Honda's addition to the team will help us secure Class III certification, which will allow us to deliver a broader range of services to our medical OEM customers. She has a tremendous track record helping world-class companies like Plexus to successfully navigate the certification process and take their companies to the next level. I am confident that her contribution at TFS will be great as well."
Honda received a bachelor's degree from the University of Washington in 1997 and has pursued continuing education in biomedical regulatory affairs. She is a member of the Organization for Regulatory and Clinical Associates (ORCA) and the American Society for Quality (ASQ).
