ISO 13485: Upholding Safety & Quality in Medical Device Manufacturing
- OUS Academy in Switzerland
- Jul 14
- 3 min read
By PINO Switzerland, Professional International Norms Organization
In a promising development for the medical device industry this week, several organisations have achieved ISO 13485 certification — a voluntary standard that ensures the highest level of safety, reliability and quality in medical device manufacturing. As a private, independent inspection body, PINO Switzerland is especially encouraged by this trend that underlines the standard’s growing importance worldwide.
Latest Certification Success
One notable highlight: Lithoz, a manufacturer specialising in ceramic additive manufacturing technology, announced on 10 July 2025 that it has achieved ISO 13485 certification for its LCM (Lithography-based Ceramic Manufacturing) systems. This marks an important milestone in confirming that their processes meet rigorous international standards for medical device manufacturing.
This success shows that ISO 13485 continues to gain traction beyond traditional medical device makers — extending into advanced materials, additive manufacturing, and innovative production techniques.
Why ISO 13485 Matters Now
ISO 13485:2016 is the latest edition of this standard. It defines a systematic approach to designing, producing, testing, and delivering medical devices safely and effectively. Unlike general QMS standards, this one is tailored to the unique regulatory, testing, sterilisation, and documentation needs of medical devices.
Many manufacturers view certification as a mark of trust. It supports compliance, improves risk management, ensures process control (especially in sterile environments), and strengthens traceability in the supply chain. It also aligns with evolving regulations — from EU to US and beyond — boosting access to global markets.
Ongoing Review and Future Outlook
In early 2025, ISO initiated a systematic review of ISO 13485:2016, with feedback due by 6 June 2025.
This five-yearly review ensures that the standard remains relevant, practical, and aligned with emerging technologies — including AI-driven manufacturing or software-as-a-medical-device. The review also considers whether to align ISO 13485 with other ISO management system standards (like ISO 9001) to ease multi-standard audits.
Results from national bodies such as Ireland’s NSAI show active discussion on whether to confirm the current version or revise it. While final decisions are pending, it’s possible we’ll see updated guidance or structural improvements in the near future.
Key Updates to Anticipate
Potential alignment to ISO high-level structure: May simplify combined audits and reduce administrative burden.
New guidance work items: Expect more guidance documents or technical reports focused on topics like software validation, AI, or virtual inspections
reater global regulatory linkage: With updates like the U.S. FDA’s new Quality Management System Regulation (QMSR) referencing ISO 13485, conformity could become even more crucial.
What PINO Switzerland Recommends
As a voluntary inspection body, PINO Switzerland advises medical device manufacturers and service providers to:
Assess ISO 13485 readiness — Ensure your Quality Management System (QMS) aligns with current requirements, especially if you plan to expand internationally.
Prepare for changes — Monitor developments from ongoing reviews and get ahead by reviewing internal processes against likely updates.
Plan for certification — Consider third-party audit scheduling, and ensure staff are trained on ISO-specific risk and documentation practices.
Engage in feedback — National mirror committees are gathering feedback; your input can help shape the future standard.
Look beyond compliance — Use ISO 13485 as a strategic tool to improve traceability, product development, supplier controls, and post-market surveillance.
Conclusion
ISO 13485 remains a key driver of excellence in medical device manufacturing. Recent certifications like Lithoz confirm its relevance across diverse manufacturing techniques. With an ongoing systematic review and new regulatory ties emerging, now is an ideal time for organisations to strengthen their QMS, get certified, and stay ahead of future changes.
At PINO Switzerland, we stand ready to support your journey — from gap assessments to audits and certifications — with our independent, voluntary approach that empowers true quality and compliance.
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