The Berlin-based specialist in the miniaturization of electronic microsystems has passed the audit for certification under ISO 13485 and thus smoothed the way for it to penetrate further into the field of medical engineering.
AEMtec GmbH, which belongs to exceet Group AG, has been servicing well known customers in the field of medical engineering since the beginning of the nineties, initially as a contract manufacturer but more recently as an electronics manufacturing service provider. Today the enterprise, which specialises in highly complex microsystems, offers services along the entire value chain including product development, industrialization, production and lifecycle management.
“To our customers, the ISO 13485 certifies that we are in a position to meet their most sophisticated demands with regard to quality, process safety, traceability and customer orientation”, explains Jan Trommershausen, CEO of AEMtec GmbH and CIO of exceet Group AG.
AEMtec focuses particularly on implants, hearing aids, image-guided systems and tele-medical applications. Customers from these market sectors can profit, above all, from AEMtec’s skills in the field of miniaturization through which it has already brought to fruition innovative products using the smallest possible installation spaces.
Further certifications are: ISO 9001 since 2002, 16949 since 2004 and 14001 since 2006.