Jack Dhuwalia is a seasoned technical manager of his own consulting company since 1993. He addressed warning letters, implemented design control systems, prepared companies for FDA inspection, conducted many verification and validations including test method validations, packaging and sterilization validations. Previously he was a section manager for Baxter Health Care, a business development manager developing Class II and III medical devices. He brings clinical experience to help design medical products. He has two patents in Cardio-Vascular systems. He has written several technical articles and enjoys teaching at technical conferences and UCI/USC.