This year was yet another challenging one for the Quality department. In 2018, and in addition to four FDA inspections, and a recertification audit for the Signia GmbH, a so-called upgrade audit for Sivantos needed to be carried out – in seven countries.

Let’s take a closer look at these upgrade audits

The standard ISO 13485 is the key requirement for our Quality Management System. Without meeting this standard’s new requirements, no device is launched. Therefore, not only our Quality department but whole Sivantos company had to make sure to implement these specifications in our processes and present the corresponding evidence that this had been done.

This proof was provided in 196 hours of auditing. The notified body authorized was TUEV-SUED. Their auditors checked compliance to global and local requirements at Sivantos in China, Germany, Hungary, Italy, Singapore, Poland, and the USA. After the final audit in Erlangen TUEV-SUED confirmed, we are on the right track. And very rightfully so. “As a Medical Device Manufacturer, we operate in a very strict and regulated environment. Zero-compromise to non-compliance is essential in everything we do, every day”, stated Thomas Hies, SVP Quality.

What are the next steps?

In 2019, the biggest challenge for the Quality department will be to implement at Sivantos the new European Medical Device Regulation (MDR), the successor to the Medical Device Directive (MDD), and to be fully compliant by the end of the year.

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