Certificates
Quality Management According to ISO 13485
ISO 13485 is an internationally recognized standard for quality management systems in the medical device industry. It defines requirements for processes used to systematically ensure the quality and safety of medical devices throughout the relevant phases of their life cycle.
For manufacturers, this means, among other things, that key processes—from development and procurement through production and quality control to documentation—are organized according to defined and traceable quality processes.
CNSAC MedShop GmbH has a quality management system certified to EN ISO 13485:2016. The certification by TÜV SÜD Product Service confirms that the quality management system meets the relevant requirements within the scope specified in the certificate.
The specific scope of application and the current certificate version can be found in the certificate provided below.
ISO 13485:2016
Development, manufacture, and distribution of non-active and non-sterile medical devices and accessories for sleep diagnostics, oxygen therapy, neurology, and cardiology (electrodes). Import and distribution of medical devices and accessories for sleep diagnostics, oxygen therapy, neurology, and cardiology.
EU Quality Management Certificate (MDR)
Medical Device Regulation
Product-Related Compliance Documents
In addition to our corporate and quality management certifications, product-specific regulatory documents and EU declarations of conformity are available for our medical devices.
