Medical device manufacturers, including dental laboratories, must implement a supplier management process to comply with FDA's quality management system regulations. They must ensure that materials and components sourced from third-party suppliers/subcontractors align with the manufacturer's standards and FDA requirements. FDA's 21 CFR 820.50 and ISO 13485:2016 in Section 7.4 detail purchasing controls and supplier evaluation. Outsourcing is common for operational efficiency, but without thorough scrutiny, companies risk compromising product safety and compliance.
The FDA is actively monitoring global supply chains and increasing inspections. It is crucial for medical device manufacturers, including dental laboratories, to safeguard their operations from Inspectional Observations, warning letters, and recalls by validating suppliers and upholding quality through a robust quality management system. Manufacturers must prioritize doing business with suppliers that not only meet but exceed customer expectations.
Consider the potential consequences:
FDA intervention leading to the halt of a supplier's product distribution.
Nonconforming products from suppliers causing disruptions in distribution.
Failure to meet customer expectations due to supplier backorders.
SafeLink can help the Manufacturer develop a supplier management process to ensure that the supplier QMS can withstand the increasingly complex regulatory environment. If the Manufacturer already has an effective supplier management process in place, then SafeLink can provide supplier audits to identify and resolve any quality issues that could put the quality of the product and the Manufacturer at risk.
If the FDA investigates a supplier or subcontractor and discovers non-compliance with quality regulations, a list of the supplier’s customers may be requested by FDA. The FDA could then visit the customers on that list to inform them to stop using the supplier and to halt the distribution or production of the affected device.
The responsibility of a Manufacturer is to ensure that the same quality standards that are promised by the Manufacturer to its customers are met by third-party suppliers of products and services. SafeLink can help you develop a supplier management process that can hold up to the more and more complex regulatory environment.
Contact SafeLink Consulting for assistance. If you need help, contacting an expert such as SafeLink Consulting is a step in the right direction. Contact us to learn how services are utilized to benefit your business to assist you in achieving a more effective quality management system!
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