Quality & Compliance
Quality, product safety and regulatory compliance are integral to all business processes at MEDENA. Our manufacturing and quality management systems help ensure that products are manufactured reliably, safely and in accordance with applicable standards and requirements.
ISO 9001:2015
ISO 13485:2016
EN ISO 22716: 2007
Our Certifications
MEDENA operates in accordance with internationally recognised quality standards and holds the corresponding certifications.
Quality in Manufacturing
Medical devices are manufactured in compliance with the requirements of ISO 13485:2016 to ensure that products meet their intended safety and performance requirements.
Our cosmetics are manufactured in accordance with ISO 9001:2015 and EN ISO 22716:2007 (Cosmetics GMP), supporting high product quality and comprehensive consumer protection.
All relevant processes – from incoming goods through manufacturing to delivery – are defined, documented and traceable.
Ready to Bring Your Product to Market?
For questions about quality, certifications or compliance requirements, please contact our Quality Management team at quality@medena.ch.