Mrs. Tracy A. Weldon has been developing high impact medical devices for more than 10 years. Tracy joined Biofisica in July 2001 to oversee the research and development efforts of the company’s first product offering, POSiFECT®, and to set-up its manufacturing processes. Under her direction, the company received its ISO 13485 certification in 2005 and the CE Mark in late 2006 allowing for the sell of POSiFECT® in Europe. She continues to closely manage both the company’s quality management system and Avail Medical, the contract manufacturer. Currently, she is leading the effort for obtaining marketing clearance from the FDA to enable the sale of POSiFECT® in the United States. Prior to Biofisica, Mrs. Weldon worked for CIBA Vision where she was the project leader for the development of various new manufacturing technologies for both class II and III medical devices. In addition, she participated on several multinational project teams which brought new breakthrough devices to market, such as the world’s first true extended wear contact lens. Mrs. Weldon has a Bachelor of Science degree in Chemistry from Georgia Southwestern College and a Master of Science in Management of Technology from the Georgia Institute of Technology. She has training and application in ISO 13485, Design Control, CFR Title 21-Part 58, and medical device regulatory compliance.
