BIOSUN – Quality from the market leader

The BIOSUN Ear Candle has been sold across the world for many years and has established as well as maintained its outstanding reputation thanks in part to its consistently high quality.

In order to be able to guarantee consistently high quality, BIOSUN has established a quality management system, which is inspected on a regular basis by the independent certifier EUROCAT. An integral component of the QM system is the development of a risk management system in line with ISO 14971.

This inspection takes place in compliance with the standard DIN EN ISO 13485, which describes an industry-specific inspection of the manufacturers of medical devices and takes place on an annual basis. This annual, so-called "audit" is supported by voluntary internal audits.

The BIOSUN quality management system describes every internal process within the company. All processes are included, from selecting the suppliers to controlling the supplied raw materials to customer service upon delivering the finished goods.