MEDICAL MOLDING PER THE FDA'S ISO 13485 AND ISO 14971 REQUIREMENTS

摘要

The FDA is becoming more stringent in auditing medical device companies (MDCs) for compliance to CFR Part 820 (QSRs), ISO 13485 (Quality Systems) and ISO 14971 (Risk Management) standards. MDCs are responsible for ensuring that both internal and outsourced plastic component suppliers meet these regulations and standards. Correlation Technology (CT) is an effective means for MDCs to flow down these requirements to their molded part suppliers. CT is an effective and efficient technology that enables molders to comply with the Quality standards, to accomplish Risk Management at the component level and to demonstrate their compliance with these requirements to both the FDA and the MDCs.