Summary
This document is a guide detailing the list of relevant subcontractors and suppliers necessary for compliance with ISO 13485 and the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). It outlines the requirements for submitting a list of subcontractors and suppliers that may impact the device, including their names, locations, activities undertaken, and justifications for not requiring an audit by SGS. The guide emphasizes the importance of providing accurate information during the application and audit processes. It also includes sections on certification requirements for subcontractors and suppliers, indicating that they should hold valid ISO 13485 certificates or equivalent. Additionally, the document provides decision trees and examples to assist in determining the relevance of subcontractors and suppliers, ensuring that those who may affect product safety and performance are adequately assessed. The document is confidential and proprietary to SGS.
