Quality

Outstanding quality - without compromise

As a manufacturer of high quality medical devices, it is our goal and commitment to consistently and exclusively deliver products of outstanding quality to customers and patients. For this reason Transcoject maintains a carefully conceived and comprehensive quality management system that is aligned with current GMP guidelines.

Successful quality management for Transcoject is a broad concept that incorporates all processes and activities of the company. The crucial element of our success and the quality of our products is our knowledgeable personnel. We ensure that our employees’ qualifications are updated on a regular basis by means of targeted education and training. Each of our 180 employees is actively involved in the quality system and understands his responsibilities as being essential for the production of outstanding quality medical products.

Certificates

Being a manufacturer  of medical devices, Transcoject is certified pursuant to the Medical Device Directive 93/42/EEC Annex II and Annex V.

Our Quality Management has been certified according to the specific medical device standard
ISO 13485 and the more general ISO 9001.

Our ethylene-oxide sterilization is certified as per ISO 11135.

As a supplier of aseptic filling of medical devices, Transcoject is also certified according to ISO 13408-1.