customer information DIN ISO 13485:2003

Frank Optic Products introduce a new quality management, as well as a clean room area based on of the European Medical Devices Directive

Frank Optic Products is certified acc. DIN ISO 13485:2003 since 09 July 2007 and therefore we meet the general German and European directives for medical devices.

We introduced a new quality management system for the design/ development, production and distribution of medical lasercables and sonds. By now on these devices are certified according to Annex II, section 3, Medical Devices Directive 93/42/EEC with the certificate CE 0535 by an accredited institute.

We also build up our new clean room type C10000 and bring in new employments of clean room typ C1000 by the introduction of our new quality management system for medical devices.

By introducing the new QM-system and the upgrade of our clean room area, we will meet the constant requirements of our customers and serve them with products of highest quality.

DIN EN ISO 13485:2001 [ PDF-Download] 370kB	EC-Certificate MDD 93/42/ECC [ PDF-Download] 710kB
DIN EN ISO 9001:2000 [ PDF-Download] 402 kB