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ALTATEC GmbH, the manufacturing arm 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 the extensive quality assurance scheme relating to the company’s operations in order to be recognized. Naturally, ALTATEC complies fully with the standard. Quite correctly, medical products and devices must meet particularly strict requirements.
The CAMLOG Group ensures that the quality of its products and services meets the expectations of our customers. Our products comply with the basic requirements defined in the European laws and directives relating to medical devices with regard to product performances and patient safety. Besides EN/ISO 13485, ALTATEC has also been certified according to BL93/42EWG for medical products.
We leave nothing to chance
ALTATEC'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 the ALTATEC GmbH, our excellently trained personnel carries out internal and external audits. Internal audits closely scrutinize our manufacturing processes; external audits inspect our suppliers.
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 made at our own locations with our own equipment.
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