Quality

Basis for our customer-focussed business processes is our day-to-day ambiton “working” according to a QM system. Development, manufacturing and distribution are in the framework of certified management system in compliance with the international standard EN ISO 13485. The medical devices meet the relevant requirements of annex II (section 3) of the directive 93/42/EEC and are CE-certified.All processes fit the quality rules of our management, which requires compliance with quality management system EN ISO 13485 (first certification in 1998 on ISO 9001:1994).

Accreditations

We are member of the “European Health Industry Business Communication Council” as well as through corresponding accreditations in some countries allowed to export medical goods without restrictions.

Single Registration Number

Below the valid single registration number for our manufacturer role.

Manufacturer: CHRN-MF-2000084