ISO 13485 Expert Witness
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Engineer, Quality Engineer, Quality Manager, Medical Devices, Auditing, ISO 9001, ISO 13485, ISO 13485:2003, QSR, Procedure Writing, CE Marketing, Quality System Regulation, Planning, Organization, Problem Analysis, Statistical Process Control, Training, 501K, Council Directive 93 42 EEC, Process Validation, Complaint Handling, AAMI 13409, Interface with FDA
Quality Management, FDA Compliance and certification of medical device manufacturing, Quality systems development, Gap Analysis, Standards Compliance, ISO QS Desk Quality Audits, Process control, Quality Manual, FDA 820 compliance, ISO 9000, ISO 2000 and ISO 13485 registration
