Sutter successfully obtains re-certification of MDD and ISO13485:2016
Last week we successfully completed our re-certification audit. During the 3-day visit our company and products were audited and confirmed according to ISO13485:2016 and Medical Device Directive (MDD). The new certificate is now valid for another 4 years.
This enables us to make the final adjustments for the new Medical Device Regulation (MDR), which will be valid from 26 May 2020. It will also give us enough time to anchor the MDR in our processes before our move to the new company building in Emmendingen in 2021.
"Although MDR will slow down the innovation and introduction of new products to the European market, we now can be sure that our product portfolio will be available to our customers in the EU without interruption", says CEO Bert Sutter. "We are pleased with the outcome of the audit. Compliance with laws and regulations plays an important role in our company".
Each day employees from all units at Sutter develop, produce and distribute medical products of high quality and precision. The successfully completed audit confirms again the high quality standards that are incorporated in Sutter’s philosophy.