MEDIGRATION QUALITY MANAGEMENT
Being a vendor of medical equipment we are very much committed to high quality of our products and services.
The council directive 93/42/EEC
and 2007/47/EG on medical device
Our products are classified and certified as follows:
- DigiRoebs class II b
- ImageBroker class I
- ImageVision class II a
- CD-Imager class I
- MammoView class I
We are fully compliant with European MDD. (CE)
Once a year we are audited by an independant institution to guarantee the high standard of our products.
DIN EN ISO 13485:2007 & DIN EN ISO 9001:2008
Quality management is much more than getting just a few products certified by a known body. For that reason we managed to have the whole company certified according to DIN EN ISO 9001:2008 and DIN EN ISO 13485:2007. Our customer can trust that our company is committed to:
- careful monitoring of customers' satisfaction
- documented processes
- continuous validation of correction measures
- permanent education of our employees
- monitoring and avoidance of systematic errors
- reduction of product risks
Certificate DIN EN ISO
9001:2008
Certificate DIN EN ISO
13485:2007
medigration Gesellschaft für medizinische Datenverarbeitung und Integration mbH
Schuhstr. 30 ▪ D-91052 Erlangen ▪ FON. +49 (0) 9131 - 69087 40 ▪ FAX. +49 (0) 9131 - 69087 50 ▪ eMail: info@medigration.de