Quality policy

Our products shall fulfil demands and expectations from customers, and our products should be considered a valuable choice on the market for its purpose.

By our products or services and through our work we shall be considered an enterprise with high quality.

Our quality policy and the work with continuous improvements shall be understood and applied by our organisation and furthermore by our sub- suppliers and distributors.

ISO 9001:2008 - ISO 13485:2003

Bioimplant Scandinavia is certified in accordance with ISO 9001:2008 since February 2010, and in accordance with ISO 13485:2003 since November 2010. We have been examined and approved by Intertek SEMKO Certification AB, which is an independent certification organisation accredited by the Swedish authority SWEDAC. The certification establishes that we fulfil the requirements of the international standard for quality management and denotes that we are working with quality in every part of our organisation.

Since March 15, 2011, the organization of Bioimplant Scandinavia was certified that the full quality assurance system confirms with the Directive 93/42/EEC on Medical Devices, Annex II. The organization is entitled to use the CE 0413 marking on those products listed n the MDD - Product List: Certificate No 41318530.