what is the difference between iso 13485 and 21 cfr 820?

Product quality depends on executing every function in the production cycle correctly, down to the last detail. These include:Įach phase involves multiple team members contributing to several complicated processes. Creating a replacement part, such as a rear assembly case for the Alaris 8100, involves four phases before market production. For example, Elite Biomedical Solutions specializes in infusion molding production of replacement components for devices like the BD Alaris IV pump. Manufacturing replacement parts involves a complex, multiphase process. What's involved in ISO 13485 quality management? It requires companies to develop manufacturing processes that mitigate risk at every step and to provide comprehensive documentation of quality verification throughout the production cycle.

ISO 13485:2016 is a quality management system designed specifically for manufacturing medical devices. ISO standards closely align with the regulatory requirements of its member countries, so ISO-certified businesses have an easier time entering the global market. These standards describe quality management systems (QMS) that help companies produce safe, reliable products across industries. ISO has developed common technical, industrial, and commercial standards that facilitate global trade. ISO refers to the International Organization for Standardization, a non-governmental organization representing 165 member nations. The fastest way to determine if a 3rd-party manufacturer aligns with OEM quality is to ask about ISO 13485 certification. That leaves decision-makers tasked with carefully vetting the manufacturing process of any potential 3rd-party parts partner. Surprisingly, 3rd-party medical device manufacturers aren’t required to follow 21 CFR 820, Quality System Regulations. Unfortunately, that's not true for all 3rd-party products on the market. However, the FDA ensures that OEM parts will always meet regulatory quality standards.

Using 3rd-party replacement parts helps lower repair costs while avoiding common OEM issues like limited availability, delayed shipping, and discontinued components. Repairing lifesaving medical equipment can significantly increase device lifespan and, therefore, ROI-but only if the repair restores OEM-level safety and functionality. According to 2021 market research, infusion pumps made by leading original equipment manufacturers (OEMs) currently range from $2,380 to $5,982. And the cost of purchasing a new medical device, such as an infusion pump or telemetry monitor, is certainly no joke.

Clinical asset purchasers have so many serious factors to consider when making decisions about lifesaving biomedical equipment.

What is the difference between iso 13485 and 21 cfr 820?