Ferenc Kazinczi

Lead Auditor at TÜV Rheinland Group

Ferenc Kazinczi has a strong background in the medical device industry, with a focus on dialysis and blood purification systems. Ferenc began their career at B. Braun Group, where they worked as a Systems Engineer for five years, leading a requirements engineering team and overseeing design control activities. Ferenc also played a key role in the development of the company's flagship CRRT device and implemented agile and SCRUM methodologies for medical software development.

After their time at B. Braun Group, Kazinczi joined NTT as a Research Engineer, where they worked for a year before moving on to Nikkiso Europe GmbH. At Nikkiso Europe, they served as a Senior System Engineer, specializing in dialysis systems. Ferenc then transitioned to Nikkiso Co Ltd, where they held positions as a Senior System Engineer and a Global Product & Project Manager. During their time at Nikkiso, they managed chronic and acute dialysis portfolios and was responsible for global product and project management.

Currently, Kazinczi is working for TÜV Rheinland Group as Global Head of Medical Software, where they oversee the development and compliance of medical software products. Ferenc also holds a position as a Lead Auditor and Medical Device Auditor at the company.

Ferenc Kazinczi's education history is as follows:

- From 2014 to 2015, they pursued a Doctor of Philosophy (Ph.D.) degree in Information Technology at Budapest University of Technology and Economics.

- Between 2011 and 2014, they earned a Master's Degree in Biomedical Engineering from Budapest University of Technology and Economics.

- From 2007 to 2011, they obtained a Bachelor's Degree in Telecommunication and Media informatics, also at Budapest University of Technology and Economics.

- In 2013 and 2014, they studied at the Technical University of Munich, specializing in Biomedical/Medical Engineering.

- In 2011, they briefly attended Aquincum Institute of Technology, though no degree or field of study is specified.

Additionally, Ferenc Kazinczi has obtained several certifications including ISO 9001 Lead Auditor - Quality Certification from IRCA in 2020, Advanced Product Marketing and Product Management from LinkedIn in 2020, FDA 21 CFR part 820 - Quality System Requirements and Industry Practice from the FDA in 2015, CPRE - Certified Professional for Requirements Engineering from IREB GmbH in 2015, Electrical Safety of Medical electrical equipment - IEC 60601-1:2005 Ed. 3rd from TÜV SÜD in 2012, and Documenting Required ISO 14971 Risk Management File Elements in the IEC 60601-1 TRF from UL in 2011.

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