Verified recordMedical Equipment Manufacturing

Thomas Kruczyk

Global Medical Device Systems Engineer at Biotronik

Based in Berlin, Germany

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Seniority

Staff

Department

Other

Location

Berlin

Industry

Medical Equipment Manufacturing

Company size

4.5K

Contact information

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t•••••••@biotronik.com

Phone

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+49 ••• •••• ••••

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Background

About Thomas Kruczyk

More than 15 years of experience in the medical device industry (software as a medical device) covering validation, verification, software development and systems engineering. Focused since 6 years in systems engineering with excellent skills in - Evaluation of new technologies in the clinical environment over the product life cycle - Technical leading of internal project teams - Establishment of collaborations for new business strategies - Coordination with and control of external service providers - Requirements Engineering including analysis, specification and alignment - Elaboration of project-related data protection concepts within the GDPR framework - Supporting risk management in risk analysis, risk assessment and risk control - Elaboration of approval strategies within the framework of the Medical Device Regulation

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