The ISO 13485 standard established by the International Organization for Standardization (ISO) specifies regulatory requirements for medical device manufacturers' quality processes. It provides a fundamental guideline for device makers’ quality compliance. ISO 13485 software helps device companies maintain an ISO 13485-compliant quality management system (QMS).
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As of March 1, 2018, all medical device certifications and certification renewals are required to align with the ISO 13485:2016 standard, which supersedes ISO 13485:2003. The standard was updated to adjust to technological advancements, modernized quality management practices and an increased regulatory focus on risk. The revision also specifies that any ISO 13485 quality system software in use must be validated and documented. Because a medical device’s success is reliant on the manufacturer’s ability to maintain quality compliance, a proven and efficiently validated ISO 13485 software system can be integral to a manufacturer’s ability to conform its quality practices to the latest requirements.
ISO 13485 compliance requires medical device manufacturers to establish satisfactory quality systems and implement quality processes that are properly documented, controlled and maintained. Reliable ISO 13485 document control software solutions allow companies to automate quality practices while providing a central repository for all quality documentation. What’s more, the increasingly global nature of the medical device industry demands the collaboration tools and supply chain oversight that ISO 13485 software systems afford. Proven ISO 13485 software systems not only streamline manufacturers’ processes and get products to market faster, they also accelerate and simplify validation activities and risk assessment/management.
To meet the current regulatory requirements set forth in ISO 13485:2016, device manufacturers need ISO 13485 quality system software that effectively helps them achieve their compliance goals by providing key capabilities such as:
For more than 25 years, MasterControl has been a leading provider of ISO 13485 quality system software to medical device manufacturers worldwide. Hundreds of medical device companies of all sizes around the globe use MasterControl ISO 13485 software to streamline and integrate quality processes. MasterControl accelerates the realization of the full business and operational benefits of ISO certification, such as:
MasterControl’s ISO 13485 document control capabilities allow device companies to automate the routing, escalation, approval and delivery of standard operating procedures (SOPs), policies and other compliance-critical information. The system also optimizes the management of audit and training programs as well as processes for handling quality events like nonconformances and CAPAs.
In alignment with the increased focus on validation highlighted in the revised ISO 13485:2016 standard, MasterControl provides the groundbreaking Validation Excellence Tool (VxT), an industry-first solution that enables companies required to conduct risk-based software validation to reduce validation times from months down to days or even hours.
The FDA’s stated mission of fostering medical device innovation reflects the pace of advancements in the modern technological era. The agency encourages the use of effectual electronic systems like ISO 13485 document control software solutions, provided the systems are appropriately validated in a manner that maximizes manufacturers’ avoidance of defects and resultant recalls. In fact, the FDA’s Office of Regulatory Affairs (ORA), the lead office for all FDA field activities, has used MasterControl since 2009 as the primary tool for its quality managers to uniformly apply and monitor work products and processes.
MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.