Certificates to download:

Certificate EN ISO 9001

Certificate EN ISO 13485

Certificate European Directive 98/78/EC IVD

EFI-Accreditation for Histocompability Testing

R.O.S.E. is a CE labelled and ISO 13485 accredited ISO 13485 manufacturer of medical devices

Quality is our top priority

In order to keep and strengthen the reputation and success of the company, the management of the company implemented a quality management system based on EN ISO 9001 and EN ISO 13485. We also provide evidence for the legal requirements according to the European Directive 98/79/EC IVD and the Medical Device Act.

Our latest success in terms of quality is the accreditation of European Federation for Immunogenetics in 2013. Our facility fulfills all the necessary requirements to provide HLA Typing Service for our customers worldwide.

The entire procedure of the production process is controlled at different points by tests and guided by the quality assurance.

  • QC of incoming, intermediate and end products
  • Fully working Quality Management System
  • Certified according to DIN EN ISO 13485
  • Certified according to ISO 9001
  • Following Directive 98/79/EG
  • CE-labelled
  • GMP-Standard
  • Continuous development of high-tech DNA products