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#Iso 13485 vs 21 cfr 820 manual
No matter where the end market is, EMMA International can help. FDA QSR 21 CFR PART 820 ' ISO 13485:2016 1 Scope 2 Normative References 4.2.1 General 4.2.2 Quality Manual 4. While the United States currently relies on the FDA regulation, many other countries depend on the ISO standard. The standard applies to all medical devices, despite the class.įundamentally, the ISO 13485 standard and the FDA 21CFR820 are not incongruent. The standard is focused on customer requirements and has specific regulations to ensure customer satisfaction throughout the entire product life cycle, including the requirement of a Quality Manual 1. The ISO 13485:2016 standard intends to standardize medical device regulatory requirements for quality management systems. These constraints ensure compliance to customer and regulatory requirements. ISO standards are global standards that specify requirements for organizations supplying medical devices. While there are some medical devices exempt from certain GMP requirements, exempted manufacturers are still required to keep conforming files and design control records 1.
ISO focuses on developing and maintaining a QMS, and Part 820 focuses on good manufacturing practices (GMPs) for medical devices.
Although becoming ISO 13485 certified will not satisfy the requirements of Part 820, there is some overlap between the two. The quality system regulation is pertinent to all finished medical devices sold commercially within the US. The FDA equivalent of ISO 13485 is 21 CFR 820. It is up to the manufacturer to determine the ways in which they intend to meet the quality system requirements. Although the regulation states quality system requirements, it is up to the manufacturers to determine which constraints are applicable to their processes and products 1.
#Iso 13485 vs 21 cfr 820 code
They are responsible for having objective evidence in meeting the established quality system requirements.įor products requiring FDA compliance, Part 820 of Title 21 of the Code for Federal Regulations (CFR) defines quality systems and good manufacturing practices for medical device manufacturers. Manufacturers are required to establish specifications for their products and processes and input a quality management system to ensure those targets are met. A well-structured quality management system helps to guarantee this. Regulations ensure medical device manufacturers produce consistent safe products.