The ISO 13485 Medical Devices standard is designed specifically for medical device companies. It has specific requirements for accountability, design controls, records retention, process control, customer feedback and more. As a business consultant, David Owen brings a wide range of experience to every project. Past work includes training for ISO 13485 Medical Devices requirements, and developing ISO 9000 business management systems.
David draws from his experience as an engineer, QA expert and management consultant. In his thirty years as a business consultant, he has worked in many industry sectors in Europe and North America. He has experience designing processes and systems to meet international regulatory standards.
David has helped many clients implement the ISO 13485 Medical Devices standard and achieve the CE mark.
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