One of the first to be ISO certified

Since our company’s beginnings in 1977, quality and the search for perfection have been our key concepts. We were one of the first companies in Denmark to obtain ISO 9001 certification. Today we are certified to both ISO 9001:2008 and ISO 13485:2003 standards. Our production meets the relevant sections of the FDA’s (US Food and Drug Administration) guideline for Good Manufacturing Practices (21 CFR Part 820 - QSR).

Our documentation provides you with full traceability

Quality and documentation are natural elements of our work.

The customer is able at all times to access data on earlier products. All our processes are well documented and documentation is archived for 10 years.

All products have control specifications which describe the scope of control checks and the required measuring equipment.

All measurements and checks are undertaken by the operators and the QA department in our own measuring laboratory.

All measuring equipment is also continually checked and calibrated to the current production run. We carry out regular process checks on moulded parts. There is also SPC on moulding weight and/or critical measurements.

Each production process culminates in a certificate which is your proof that each and every product has been checked with regard to the agreed parameters