DIN EN 13485:2016

The international edition of the requirements for the QMS of a medical device manufacturer was published at the end of February this year. The German edition as DIN EN ISO will follow in the next few weeks – for now – there is no information. We at Qualitätsplan are also looking forward to the new issue in order to find out what exactly will change for our customer.

Why isn’t Qualitätsplan offering it yet, based on the existing ISO?

Over the last few years, we have found that many new standards are releasing Z attachments, which offers loads of potential for surprise. Therefore, we are waiting for the EU edition of the standard. Why? Because we want to enable our customers not only to meet the new standard, but also the current MDD.

If you would like information on the changes to Quality Regulations' regulations and related offerings, call us on 0451-61911700 or email us at vertrieb@qualitaetsplan.net. We keep you up to date and offer you - as usual - not only information about the problem, but also the solution!