Carl Alletto, has a broad range of experience and expertise in the development and implementation of Quality Assurance Principles, Software Quality Processes, ISO Registration/Certification, and FDA Good Manufacturing Practices.
He has over 30 years of experience in the medical device industry in R&D, regulatory and quality assurance fields and has worked in both Europe and the USA.
Carl has successfully developed strategies and submitted over 100 FDA premarket notifications, (510(k) submissions), for medical imaging devices, X-ray film handling equipment, medical laser printers, and Picture, Archiving, and Communication Systems.
Carl is a Certified Quality Manager, Certified Quality Auditor and Certified Software Quality Engineer by the American Society for Quality (ASQ).
With his deep and wide experience in Quality/Regulatory fields, especially in the Medical industry, Carl can help organizations charter this tricky and challenging terrain by providing wise counsel on launching products, creating a structured roadmap for a QMS/Regulatory system implementation and also help in the ongoing upkeep of such systems.