With the publication of the international standard ISO 13485:2016 in March 2016, the latest EN ISO 13485:2016 was published as well. The European version is not a harmonized standard yet in relation to the Medical Devices Directives though. The German version - DIN EN ISO 13485 - will be published in the course of this year. The validity of the EN ISO 13485:2012 ends on 31st of March 2019. Commencing March 2016, companies have approximately three years left for their quality management system to be adapted with the new legislative requirements of EN ISO 13485:2016.
The latest version of the EN ISO 13485 has not experienced a huge revolution in comparison to its predecessor. However, many requirements are more specified which should the user to get a better understanding of this standard.
For further information about topics of quality management, we are happy to support you. Please feel free to contact us via email to give us the opportunity to discuss your individual requirements. We are looking forward to hear from you.