In previous posts, we began the conversation around the critical regulatory requirements and specifications associated with developing medical devices. So far, at a high level, we’ve discussed IEC 60601 (Safety and Performance), ISO 14971 (Risk Management) and IEC 62304 (Software Lifecycle). In this post, we’ll cover ISO 13485, which addresses Quality Management Systems for medical devices and related services.
As we often discuss, development of a medical device that is safe for both users and patients requires a strict attention to detail and a commitment quality. A well documented, auditable quality management system helps ensure that products developed to meet the high standards needed. ISO 13485 provides the guidance for quality management systems.
Based on the ISO 9001 standard, and as defined by the International Organization for Standardization, “ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.”
At a high level, ISO 13485:2016 identifies the requirements of the Quality Management System(QMS). For example, the QMS must be established and documented, committed to by upper management and supported by appropriate resources. In addition, the QMS should define the design, development, production, and service of products and control, analyze and improve any non-conformance issues.
Often an outsourced development partner will say that they have a quality management system in place. But the reality is that the QMS has never gone through the rigors of an audit or other oversight.
In a highly regulated industry such as medical devices, it is critical to partner with a company that complies with the process controls required under the Quality System Regulations of Section 21 of the Code of Federal Regulations Part 820 and International Organization for Standards 13485.
Resolution Development takes quality very seriously. Our quality management system has been put to the test over many projects of all device classifications and passed multiple audits by external sources. In many cases, our quality management system was selected by Fortune 500 companies for the development of Class II and Class III medical devices. We understand what it takes to develop a high-quality medical device under the umbrella of an efficient, compliant, and auditable quality management system.
To learn more about Resolution’s Quality Management Systems, visit our Quality Page and review our development map.