ILUMARK receives ISO Certification

March 24th

Feldkirchen, 24. March 2010 – ILUMARK announces that it has received Certification according EN ISO 13485:2003 + AC:2007 in January 2010. With this certification the notified body LGA InterCert confirms that ILUMARK has successfully introduced a quality system for the development, production, final inspection, sales and distribution of sterile reflective navigation marker as used in combination with image guided surgery systems. In addition, important quality aspects of the Class 1 product have been successfully confirmed within the MDD 93/42/ECC, Annex V.

“We feel very motivated by this achievement”, says Holger Rossner, CEO of ILUMARK. “Beyond the must-have aspect of such certifications in the medical device industry, the ISO certification constitutes an important trust basis for the relationship with our clients”, continues Mr. Rossner. “The timing of this milestone correlates very well with our sales and marketing strategy for the European market.”

With the introduction of a new production process, ILUMARK offers retro-reflective markers for the use with image guided surgery systems at a significantly reduced price compared to existing market prices. ILUMARK Navigation Markers are highly precise and fully compatible to existing navigation systems.

Download ILUMARK CE Certificate ISO 13485:2003 + AC 2007

Download ILUMARK Quality Assurance System MDD 93/42/ECC, Annex V