The USA FDA Quality System Regulation 21 CFR 820.50 Purchasing Controls, as well as similar global standards, requires medical device manufacturers to evaluate third-party suppliers of sub-components for their ability to meet certain requirements, including quality requirements. When medical device manufacturers use third-party components such as NI hardware or software in their devices, the manufacturers are responsible for ensuring the ultimate safety and effectiveness of the medical device in which the third-party components are used. Similar supplier control requirements are mandated in countries that apply ISO13485 guidelines.
Medical device manufacturers ask that their suppliers provide information to assist them in meeting FDA requirements, to communicate product issues and changes, and to perform quality assurance and configuration management for the products.
Upon request, NI offers published information that medical device manufacturers may find helpful when working to qualify NI as a supplier for inclusion in compliance-related vendor qualification files and for use in premarket submissions to the FDA or other regulatory agency. In this document, NI summarizes and identifies information and services to assist medical device manufacturers in the following efforts:
• Evaluate and document NI and its products for the validation process, including quality criteria
• Use NI products in a safe and effective manner during medical device design and test
• Satisfy regulatory requirements for information in premarket submissions for off-the-shelf software and hardware components from NI
Figure 1. Vendor Qualification Overview
Originally Authored By: Greg Crouch, National Instruments