SMTEC AG has successfully obtained certification to ISO 13485:2016, the internationally recognised standard for quality management systems in medical technology.

With this certification, SMTEC expands its existing portfolio of certificates comprising ISO 9001 (quality management) and ISO 14001 (environmental management), confirming its competence as a reliable EMS partner for the medical technology industry.

What does this mean for our customers?
ISO 13485:2016 places particularly high demands on traceability, risk management and process stability, factors that are critical in the development and manufacture of medical devices. The certification documents that our processes, systems and teams consistently meet these stringent requirements.