The International Organization for Standardization (ISO) has announced that the widely adopted ISO 13485:2016 and ISO 14971:2019 standards governing medical devices will not undergo revisions at this time. This update on medical device quality and risk management standards comes following the recent ISO/TC 210 plenary meeting.
Key Insights from the Standard Revision Process
- Status Quo for ISO Standards
After careful evaluation, ISO determined that both ISO 13485 (Quality Management System for medical devices) and ISO 14971 (Application of Risk Management to medical devices) are still effective and relevant. Both standards will retain their current versions, ensuring continuity and stability for the industry.
- Brazil’s Role in the Voting Process
One significant development during the plenary meeting was the role of Brazil’s vote in the revision discussions. While specific voting details remain internal, the outcome reflects a collective decision by global stakeholders to maintain the current frameworks.
- Benefits for Medical Device Manufacturers
The decision to keep these standards unchanged provides stability for medical device manufacturers who have already implemented these systems. It enables businesses to focus on strengthening compliance, rather than adapting to new requirements.
- Streamlining Processes with Modern Tools
The evolution of Quality Management Systems (QMS) highlights opportunities for process innovation. Solutions like V-Apps Cloud are paving the way for streamlined operations in areas such as tools, maintenance, audits, supplier management, document control, and training. Efficiency and compliance can now go hand-in-hand, thanks to modern cloud-based technologies.
What Does This Mean for You?
If you’re a medical device manufacturer, quality manager, or regulatory affairs specialist, this update ensures that your current quality and risk management systems remain compliant without the need for immediate changes. Focus can now shift to enhancing operational efficiency and leveraging tools like V-Apps Cloud for improved processes and long-term success.
Stay informed to maintain your competitive edge!
Free white paper about ISO 13485
To provide further insights, a white paper on ISO 13485 is now available for download. This resource is designed to help medical device manufacturers better understand the standard and optimize their compliance strategies.
Fill out the form below to download our white paper.
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