STERILIZATION AND ISO 13485 AUDITOR
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-Auditor for medical devices, certified in ISO 13485, MDD93/42 and MDR (EU) 2017/745 and ISO 9001. Technical expert in audits for sterile medical devices and animal tissue, for implantable medical devices.
-Expert in the verification and validation of sterile barrier packaging processes.
-Expert in conducting audits for the installation and qualification of facilities and cycles, for sterilization processes by: ethylene oxide, gamma radiation, e-beam, wet steam, dry heat, filtration, depyrogenation, glutaraldehyde, hydrogen peroxide, processes aseptic.
-Expert in verification of slaughterhouse facilities, for extraction and recovery of animal tissue, for use in human implantable medical devices