ISO13485 / 9001 Procedures

New Sales and Distribution Business being started with an established product line requires operating procedures to be written that meet all requirements of ISO13485. Procedures cover all ISO13485 requirements from order management, fullfillment and inventory management to documentation control. Business is small (1 to 2 persons), product line is 80 items ("class 2" medical devices), manufacture is subcontracted to ISO13485 certified manufacturer, no "design" requirements. Procedures supplied will be implemented and subjected to audit for ISO13485 certification. ## Deliverables Complete, implementation-ready written procedures that will allow ISO13485 certification upon third party certification audit. All oprocedures to be supplied in electronic format (MS Word or Text format) All deliverables will be considered "work made for hire" under U.S. Copyright law. Buyer will receive exclusive and complete copyrights to all work purchased. ## Platform Word or Text