As a medical device manufacturer, Corscience is well acquainted with the relevant licensing requirements. We are committed to satisfying and indeed exceeding our partners’ and customers’ quality standards. To ensure precisely this, in December 2017 we were re-certified in accordance with EN ISO 13485:2016 with flying colours. In addition, Corscience provided assistance and advice to its long-term partner Cardia International A/S with its successful bid to become certified in accordance with EN ISO 13485:2016 for the first time.
EN ISO 13485:2016 represents a major revision of EN ISO 13485:2012. Appendix A of this standard lists a total of 13 new and 43 amended requirements, but just one deletion. New important aspects such as a risk-based approach for the QM system have also been introduced. With the inclusion for the first time of UDI (unique device identification), this standard anticipates MDR issues. Other aspects also make it clear that EN ISO 13485:2016 must be seen as an important milestone for MDR; for example, the inclusion of the roles of manufacturer, importer, dealer and authoriser as well as the new “medical device file” chapter.
We are now looking forward to being presented with this new certificate. We will use the next two years to focus on the changes to the MDR. Should you have any questions as regards EN ISO 13485:2016, MDR or your QM system, please do not hesitate to contact us.