The ISO 13485 standard, established by the International Organization for Standardization (ISO), is a set of internationally-recognized quality management system requirements. The standard includes guidelines that apply specifically to medical device development, such as design control, risk mitigation, and supply chain management.
Compliance with the quality system regulations requires operational efficiency, significant attention to detail, and minimal errors. Automating quality processes, such as document control, increases process efficiency and accelerates regulatory compliance.
The ISO 13485 standard is designed for organizations involved in designing, developing, installing, and servicing medical devices to demonstrate compliance with regulatory requirements. It can also be used by internal and external auditors to help with ISO auditing processes.
The ISO 13485 standard includes requirements for a quality management system where a medical device manufacturer needs to demonstrate its ability to consistently develop medical devices that meet applicable regulatory requirements. Some of the key requirements of an organization’s quality management system include:
MasterControl’s quality management solutions enable companies to integrate and streamline all quality processes to more easily comply with FDA regulations and the ISO 13485 standard. Automating your quality management processes improves your operational efficiency, reduces costs, and accelerates your time to market.
MasterControl solutions are used by the most trusted leaders in life sciences and manufacturing industries, including the U.S. Food and Drug Administration (FDA). Since 2009, the FDA’s Office of Regulatory Affairs (ORA) has been using a variety of MasterControl’s Quality Excellence™ solutions across all of its business units.