Why manufacturers of medical devices cannot do without this standard
ISO 13485 is the internationally recognized standard that defines the requirements for a comprehensive quality management system (QMS) for the design, development and manufacture of medical devices, as well as related services. It is based on ISO 9001 and supplements it with industry-specific requirements, with a particular focus on product safety, validation and traceability, as well as regulatory compliance.
The standard addresses various phases of the life cycle of a medical device, including development and production, as well as storage, distribution, installation and maintenance. It requires a risk-based approach, comprehensive documentation and effective procedures for measurement, analysis and improvement. A documented QMS is essential in this context. ISO 13485 explicitly requires extensive documentation of quality-relevant processes and records as evidence that these processes have been carried out as planned. In quality management and audit practice, the phrase “If it is not documented, it did not happen” is therefore frequently used, even though it does not originate from the standard itself.
For medical device manufacturers, ISO 13485 certification is not mandatory. The European Medical Device Regulation (MDR) requires a quality management system and the harmonized EN ISO 13485 provides a recognized basis for it. Compliance with the harmonized version of the standard creates a presumption of conformity with the QMS requirements in the context of CE marking under the MDR.
The Vanguard quality management system is certified for both the manufacturing and the reprocessing of medical devices, by two different notified bodies: TÜV Nord and the British Standards Institution (BSI), one of Europe’s largest certification bodies for medical devices. In CE reprocessing, the reprocessor assumes all rights and obligations of a medical device manufacturer and therefore fulfils the same fundamental regulatory requirements as the original equipment manufacturer (OEM).
“Our ISO 13485 certification demonstrates that we fully shoulder the responsibilities of a manufacturer, applying the highest quality and safety standards,” emphasizes Ulrike Marczak, Chair of the Management Board of Vanguard AG. “This sends a clear message: as a medical device manufacturer, we are subject not only to the same obligations as OEMs, but we also go one step further in terms of quality and safety by inspecting each product individually.”
The current certificates are available for download in the Vanguard AG download section.
