High quality products are not only created through excellent specialist knowledge and many years of experience, but also through sustainable quality management.
Our quality management system according to DIN EN ISO 13485 applies to all business areas of HELORA Oberflächentechnik GmbH.
The management commits itself to maintaining the quality management system, the continuous improvement of the associated services, the provision of necessary resources and the performance of regular assessments. The regulations of the QM system are binding for all employees in the company.
Our company has dealt with the regulatory QM requirements of the medical device industry from the start.
We are certified according to DIN EN ISO 13485 and meet the requirements of the FDA guidelines
QSR-Standard FDB 21 CFR 820 (not certified).