Quality, safety and competitiveness are crucial to us. As part of ensuring that our products comply with applicable requirements and legislation at any time, we have been certified. This ensures continuous development through ongoing analysis and evaluation.
We have developed a quality management system that meets requirements of ISO 9001: 2015. It helps us in our work to ensure the high quality and efficient execution of processes. The certificate covers our full product range. A copy of the certificate can be downloaded here (.pdf)
DS/EN ISO 13485:2016
The quality management system is built on ISO 9001 and covers our range of medical equipment (class 1 + class 1m). There are more stringent requirements for medical devices, especially with regard to traceability and risk management. This ensures that we always deliver products that meet the highest safety standards. In May 2018, we were upgraded from the 2012 version to the latest 2016 version of the standard. A copy of the certificate can be downloaded here (.pdf)
Our range of class 1m medical devices are certified according to Directive 93/42/EEC, Annex V. A copy of the certificate can be downloaded here (.pdf)
Furthermore, Carina Plastics is registered as a manufacturer of medical devices by the Danish Medicines Agency and by the Ministry of Environment and Food of Denmark - Danish Veterinary and Food Administration as a manufacturer of food contact products. Download the latest control report here.