Operon Strategist is the medical device and regulatory consulting providing services to medical device and primary packaging material manufacturers. We assist manufacturers with complete turkey project which includes manufacturing plant layout design, QMS certification for their product and we also help them in Design and Development of the medical device, combination products, etc. ISO 13485, ISO 15378, CDSCO, FDA, CE Marking, FDA 21 CFR Part 820, FDA 21 CRF Part 210 and 211, FDA 21 CFR Part 820.30, CAPA Management.