Ed Panek

Ed Panek brings over 20 years of quality and regulatory experience in the development and manufacturing of medical and industrial products and a deep domain experience with ISO 9001, 13485, 14971 and 21 CFR 820. Ed has experience internationally with the MDD and MDR in Europe as well as medical device regulations in Canada, the UK, and Australia. Ed is a member of the Regulatory Affairs Professional Society (RAPS) and advises and moderates on numerous international quality forums regarding medical devices.

Prior to Blue Spark, Ed designed and implemented customized quality systems for research at the Cleveland Veterans Administration Medical Center, Cleveland Clinic, and University Hospitals. Ed served 6 years in the United States Navy as a Radar and Waveguide Repair Electronics Technician E-5 and is a Gulf War veteran.