Soluscope Automated Endoscope Reprocessing portfolio and site achieved MDR certification

Ecolab’s Endoscopy reprocessing solutions and site are amongst first to achieve the stringent European regulation for medical devices.

September 03, 2024
Soluscope office front view

Ecolab, a global sustainability leader offering water, hygiene and infection prevention solutions, proudly announces that it has received the certification under the European Union Medical Device Regulation 2017/745 (EU MDR) for its Soluscope site and portfolio. This achievement demonstrates that Soluscope-branded medical devices meet stringent safety and performance requirements set by EU regulatory authorities.

Ecolab underwent meticulous evaluation of its safety, quality, and adherence to clinical requirements as part of the certification process. Rigorous trial testing and ongoing surveillance ensure that our devices consistently meet the highest standards.

By complying with the MDR regulation, we have strengthened processes to ensure the highest level of monitoring and surveillance of medical devices we produce and distribute, providing quality solutions to healthcare facilities across the world. The certification reinforces our commitment to quality, patient safety, and regulatory excellence.

“This first MDR certification of our Soluscope portfolio is paving the way for a set of CE-marked innovations we will be launching in the coming months. It provides a stamp of quality and safety to the hundreds of healthcare facilities we partner with”

Christophe Duhayer

Senior Vice President and General Manager, Ecolab Healthcare Europe

 

The first solution to launch under this new MDR certification is the Serie XS, an exclusive automated solution for small endoscopes that offers a rapid ISO15883-1&4 validated cycle including full traceability to reduce the risk of contamination. 

Ecolab’s MDR certification of its Soluscope portfolio will continue to support its continued growth in the automated endoscope reprocessing sector and bolster its global expansion. 

 

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