Cepk
Specialized in CE, FDA and UKCA for Medical Devices and AI products. We ensure compliance and offer a wide range of quality assurance and regulatory services: ISO 13485 (QMS), ISO 27001 (ISMS), ISO 27701 (PIMS), ISO 42001 (AIMS), Medical Device Regulation (MDR), Medical Device Directive (MDD) transition to MDR, FDA submission (510k, PMA, De Novo), EU AI Act. https://cepk.dk
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- 1técnico em desenvolvimento de sistemas
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