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COMPANY > QUALITY

Not all lubricant gels are equal

Certified quality management – for your safety – Made in Germany

Premium quality is a claim that we are committed to at LIVONDO and which is also confirmed to us by our customers. Apart from lots of praise, we have also received recognition for our products in the form of accolades. For example, hydrogel developed and produced by us has been very well rated and we won the innovation award of CV Magazine as “Best Full-Service Medical Lubricants Provider”. And the 80 million complaint-free applications also underline our quality standards.

 

In August 2016 LIVONDO was successfully certified in accordance with the standard DIN EN ISO 13485:2012 for “Manufacturing and marketing of water-based and silicon-based medical lubricants”.

 

Quality assurance of production in accordance with Annex V to the Medical Devices Directive
The production of our lubricants takes place in accordance with Annex V to Directive 93/42/EEC concerning medical devices. The products are manufactured in accordance with the quality assurance system of the area of application of the directive certificate described in Annex I.

 

Quality management DIN ISO 13485
We follow the quality management standard DIN ISO 13485 “Medical devices – Quality management systems – Requirements for regulatory purposes” in the manufacturing and marketing of water-based and silicon-based medical lubricant gels.
And our suppliers also keep and maintain a quality management system.

 

Formulae available immediately
Products produced by us bear the CE mark and are placed on the market as medical devices of class I and IIa. Our customers profit from our approved and award-winning formulae, which are available immediately. Large trading brands and the TOP 10 customers in the condom segment of European retailing rely on the quality of LIVONDO.

 

Test us and be convinced by our first-class products!

CERTIFICATION, AUDITING, QUALITY ASSESSMENTS


Auditing
2006 TÜV Rheinland, DIN EN ISO 13485:2012/AC:2012

Own certificates
2016 DIN EN ISO 13485:2012
2016 directive certificate
Certificates – safety representative MPG §30 and medical device adviser MPG §31

Quality assessments
Innovation Award of CV Magazine