Raguse Gesellschaft für medizinische Produkte mbH
Südfeld 6
D-59387 Ascheberg-Herbern
+49 (0)2599 9391-0
Montag - Donnerstag: 08.00-16.30 Uhr
Freitag: 08.00-13.15 Uhr
Individual Medical Devices for Professional Patient Care

Quality Management

At Raguse Gesellschaft für medizinische Produkte mbH we ever since attach great importance to high quality. Only with products and services of highest quality we achieve our most important objective: completely satisfied customers

The guidelines of our quality management and regulatory affairs department are hence

  • the professional guidance of the production of high quality and well elaborated sterile and non-sterile medical devices, meeting the requirements of both the high demands of our customers and the valid bodies of laws and rules for the production of medical devices,
  • quality assured development of exactly fitting solutions to our customers’ questions and requests
  • constant actualization and development of our companyinternal regulatory and qualitative expertise

As a European medical devices manufacturer we are liable to the German Medical Devices Law (MPG) and the Council Directive 93/42/EEC. In the middle of the year 1990 we already started implementing an integrated quality management system. Since 1998 the Raguse Company is certified according to the 93/42/EEC directive.

Since then our company is monitored on a regular basis by the certification and testing agency MedCert as a notified body.

As part of regular audits of our notified body the evidence has been provided that all our 3 locations fully comply with the requirements of 93/42/EEC as well as ISO 13485.

The Raguse Gesellschaft für medizinische Produkte mbH holds the following certificates which can be provided on request anytime:

  • DIN EN ISO 13485
  • Annex II 93/42/EEC
  • Annex V 93/42/EEC

Certified ISO 13485 MEDCERT