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 will be 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.

 

Further Questions

Sutter Medizintechnik GmbH will store and process your personal data solely for the purpose of responding to your inquiry and providing support for that purpose. In order to follow up your inquiry Sutter may also forward your data to our distribution partner in your home country. Further details on the processing of your personal data can be found in our privacy statement.
By submitting this contact form I consent to the processing of my personal data.

Share

Fields marked with * are required.

Please note: Your email address is only used as the sender address and not used for newsletters or promotions.