Regulatory requirements for medical device companies seem to constantly undergo review and change, with increased emphasis on specific aspects based on recall, error and warning letter trends. Recent recalls of medical devices due to failures of critical components and services supplied to device manufacturers have resulted in increased scrutiny of Purchasing and Supplier Controls. The result is that manufacturers now bear the responsibility for every step in their supply chain to ensure they provide quality finished medical devices beyond what can be achieved through testing and inspection, meaning overall quality depends on quality of raw materials, components and services. In addition, manufacturers must make sure that all aspects of the supply chain are compliant with regulatory and quality system requirements.
Upon completing this course, participants should be able to:
Understand the purchasing and supplier control requirements of the FDA QSR, EU MDR and ISO 13485: 2016
Evaluate effectiveness and applicability of these controls for their suppliers, raw materials, components and services using a risk based approach
Develop successful quality plans for incorporating requirements into the quality system
Who will Benefit:
This course is designed for people responsible for following purchasing procedures, those tasked with developing and improving purchasing and supplier controls including approval of suppliers, components, raw materials and services, and individuals responsible for quality management system improvements and compliance.
Following personnel will benefit from the course:
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