ALTATEC GmbH, the manufacturing unit of the CAMLOG group, is subject to regulation of its quality assurance system under the EN/ISO 13485 standard at every stage of its operations. This standard specifies in detail all the criteria that must be met by a company’s quality assurance scheme involving all business operations in order to be acknowledged. Undisputedly, medical products and devices must meet particularly strict requirements.
Regarding product performance and patient safety, our products comply with the essential requirements defined in the European laws and directives relating to medical devices. Besides EN/ISO 13485, ALTATEC GmbH has also been certified according to BL93/42EWG for medical products.
ALTATEC GmbH’s quality management consists of an experienced team ensuring inspections and documentation of all our products through the various production stages. In the quality management of ALTATEC GmbH, our highly trained staff carry out internal and external audits. Quality management is not static, but process-oriented and quality assurance acts on a future-oriented basis. We control the quality of our products for consistency and sustainability in long-term tests conducted at our own locations with our own equipment.
EC Certificate G1
EC certificate G1S