Artimplant maintains control over the entire process of producing the biomaterial Artelon® from development, through production to finished implants. By doing so we ensure that we maintain control of product quality.

Production takes place at Artimplant’s own facilities in Gothenburg, Sweden. The production premises and machinery have been adapted and built up for the sole purpose of producing Artelon® and they are operated by qualified personnel. Production has been refined gradually over the years to improve capacity and productivity in preparation for the increased demand for Artelon® products.

Quality Management

Artimplant has implemented a quality system in accordance with the standard 13485:2003, Quality management systems - Requirements for regulatory purposes. The quality system meets the applicable requirements stated in the Medical Devices Directive 93/42/EEC (Medical Devices) in order to obtain market entrance into the European Union.

The quality management system has been audited by Artimplant’s Notified Body, Lloyd’s Register Quality Assurance, and Artimplant has been granted certificates to prove compliance with the standard and regulations mentioned above. Furthermore, the system is designed to comply with the US requirements stated in 21 CFR, Part 820.

Clearance to market - regulatory aspects

In order for Artimplant to be able to market and sell its degradable implants, the regulatory requirements must be met in all the markets where the products are to be sold. The aim is to ensure that products that come on to the market always comply with the high quality and safety stipulations laid down by the company and the regulatory authorities.

Ultimately, it is a question of guaranteeing the patient’s safety.