Tes­ted and cer­ti­fied

MDR — more safety

Our pro­ducts bear the CE mark and com­ply with the latest EU requi­re­ments.


In accordance with the Medi­cal Devices Regu­la­ti­on (MDR), all Visa­ll pro­ducts are ful­ly iden­ti­fia­ble (uni­que device iden­ti­fier — UDI) and traceable in the decla­ra­ti­on of con­for­mi­ty. For medi­cal devices, such as Visa­ll spec­ta­cle len­ses, the decla­ra­ti­on of con­for­mi­ty in accordance with the MDR is an essen­ti­al docu­ment. This decla­ra­ti­on aut­ho­ri­ses Visa­ll to affix the CE mar­king to its pro­ducts. It also ser­ves as an assu­rance that the medi­cal device in ques­ti­on meets the exis­ting basic safe­ty and per­for­mance requi­re­ments.


Visa­ll Swiss AG is also reco­g­nis­ed by Swiss­me­dic, the Swiss regu­la­to­ry and super­vi­so­ry aut­ho­ri­ty for medi­cinal pro­ducts and medi­cal devices, as a manu­fac­tu­rer, importer and repre­sen­ta­ti­ve.

ISO certifications — tested quality

We are con­stant­ly working to beco­me even bet­ter. That is why we have what we do che­cked by reco­g­nis­ed bodies and insti­tu­ti­ons. This appli­es to ever­y­thing we do tog­e­ther at Visa­ll: from our len­ses and our ser­vices to our eco­lo­gi­cal stan­dards. We were cer­ti­fied to ISO 9001 for the first time back in 2011. Sin­ce then, we have con­ti­nuous­ly impro­ved our pro­ces­ses and had them objec­tively audi­ted by exter­nal cer­ti­fi­ca­ti­on bodies. The ISO 9001 qua­li­ty manage­ment stan­dard is the most wide­ly used stan­dard in qua­li­ty manage­ment (QM) both natio­nal­ly and inter­na­tio­nal­ly. The intro­duc­tion of this stan­dard helps us to impro­ve the com­pany’s per­for­mance on all levels. With ISO 13485 cer­ti­fi­ca­ti­on, we have gone one step fur­ther and crea­ted the requi­re­ments for a com­pre­hen­si­ve qua­li­ty manage­ment sys­tem for the design and manu­fac­tu­re of medi­cal devices.


To ensu­re and demons­tra­te that we con­ti­nue to attach gre­at importance to the respon­si­ble use of natu­ral resour­ces in the future, we suc­cessful­ly under­went cer­ti­fi­ca­ti­on in accordance with the EN ISO 14001 envi­ron­men­tal stan­dard in 2023. Like all ISO cer­ti­fi­ca­ti­ons, this is strict­ly regu­la­ted and is moni­to­red annu­al­ly.

Climate certificates — sustainable protection

We take respon­si­bi­li­ty for future gene­ra­ti­ons.

For this reason, we have Visa­ll GmbH’s green­house gas emis­si­ons regu­lar­ly recor­ded and off­set them by purcha­sing “cli­ma­te pro­tec­tion cer­ti­fi­ca­tes” (car­bon cre­dits) — more than 700 of them sin­ce 2019. We use the­se cer­ti­fi­ca­tes to sup­port green pro­jects such as refo­re­sta­ti­on in Uru­gu­ay, wind farms in Paki­stan, a well instal­la­ti­on in Rwan­da, a run-of-river hydro­power plant in Gua­te­ma­la, rain­fo­rest pro­tec­tion in Bra­zil and a hydro­power plant in India. Visa­ll recei­ves the “cli­ma­te-neu­tral com­pa­ny” award every year for off­set­ting green­house gases.

Would you like to know more about our certifications?

Carsten Mertens

Director Sales and Operations

+49 7621 91490–0

Contact us.

Absenden

Just a pho­ne call away:

+49 7621 9149–00

We look for­ward to hea­ring from you:

service@visall.de

When you can reach us:
Mon. — Fri. from 8:00 to 18:00