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Since 1996, Mark Kaganov worked for a number of world’s leading registrars and notified bodies as a Lead Auditor. His qualifications include ISO 9001, ISO 14001, ISO 13485, Medical Device Directive 93/42/EEC and Canadian Medical Device Regulations. In early 1998, Mark Kaganov led the first registration assessment in North America to the ISO 13485:2003 standard for medical device manufacturers. His industrial experience covers plastics, electronics, optics, aerospace, automotive, defense, medical equipment manufacturing and others.