Katja Koskinen
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Executive Summary
Katja Koskinen is an experienced medical devices quality and design development specialist with 15.5 years of work experience. She is skilled in various areas such as usability, ISO 13485, regulatory affairs, test automation, and testing. Katja has worked in the medical device industry, demonstrating her expertise in the design process and certification process. She has a strong background in clinical evaluations, FDA GMP, usability engineering, and software requirements. Katja has also demonstrated proficiency in the production line and has certifications in ISO 13485 QMS management and certification. She is currently working as a Regulatory Officer at Lapsi Health in the Netherlands.
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Lapsi Health
Chief Regulatory Officer&Regulatory Officer
Chief Regulatory Officer
Regulatory Officer
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