Sofia Bergh
Senior Regulatory Affairs Specialist at Cochlear
Based in Kinna, Sweden
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Seniority
Manager
Department
Science
Location
Kinna
Industry
Medical Equipment Manufacturing
Company size
4.8K
Contact information
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s•••••••@cochlear.com
Phone
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Background
About Sofia Bergh
Curious MScEE with a strong interest and passion for Medtech. Have a very structured way of working and is really good with details. High level of documentation, understanding the importance of keeping traceability from user needs/requirements throughout the verification and validation process. SME within design V&V, electrical safety type testing, good documentation practice (GDP) and usability. Vast knowledge in IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 62366, ISO 14971, and QSR Design Control. Qualified internal auditor within ISO 13485.
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