We do not compromise on quality. The most important criteria are compliance with specifications, laws, standards and environmental considerations. With our quality management, we ensure that there is complete traceability.
ISO 9001 & ISO 13485
Our management system is ISO 9001 and ISO 13485 certified. With the successful ISO 13485 certification, we have proven that we apply a comprehensive quality management system for the manufacture of medical devices. ISO 13485 contains detailed requirements on topics relating to the manufacture and marketing of medical devices. This standard, which is groundbreaking in the healthcare sector, takes into account the high requirements for devices and systems used in the diagnosis and treatment of patients.
ATEX & IECEx
In addition, we are ATEX and IECEx certified which confirms the safety of our product developments in potentially explosive atmospheres. These international certifications ensure that our solutions meet strict requirements in terms of design, material selection and protective measures to guarantee reliable and safe use in environments with potentially explosive gases, vapours or dusts. This gives our customers worldwide the assurance that our solutions meet the highest safety standards when required – even under demanding operating conditions.