Nilaykumar Patel MSc, MBA Candidate

Nilaykumar Patel MSc, MBA Candidate has a diverse work experience. In 2004, they were a Professional Cricketer in Germany Cricket Champions League. In 2010, they Co-founded and was a German Language Teacher/Foreign Education Consultant at Khodiyar International Education (KIE) Pvt. Ltd. In 2011, they were a Business Development Manager at Schneider Electric Distributor, S.Kumar Computers Pvt. Ltd. and a Business Associate at Honeywell & Cisco Distributor, ConnectedHome-Kirti Telnet Pvt. Ltd. In 2012, they were a German HelpDesk Adviser/Service Support Analyst at Solid Systems Global. In 2014, they were a Lab Assistant at Ludwig Boltzmann Institute for Experimental and Clinical Traumatology. In 2015, they were a Research Assistant at AIT Austrian Institute of Technology GmbH. In 2016, they were a Research Laboratory Technician at Department of Pharmacognosy, University of Vienna. Since 2019, they have been Chief Quality Officer and Quality and Regulatory Affairs Manager at contextflow. In this role, they have been responsible for maintaining an effective Quality Management System, implementing Cybersecurity Requirements for Medical Devices, performing Internal Audits, organizing and accompanying 3rd Party Certification and Surveillance Audits, implementing MDSAP, filing and submitting regulatory documents, ensuring compliance with other required standards, and organizing in-house training. Nilaykumar has achieved successful co-establishment and implementation of a QMS from scratch within 4 months, and has published expert articles and given expert talks on topics related to regulatory affairs.

Nilaykumar Patel MSc, MBA Candidate has an extensive educational background. Nilaykumar completed a Bachelor of Engineering in Biomedical Engineering from Fachhochschule Technikum Wien in 2015. Nilaykumar then went on to pursue a Master of Science in Molecular Biotechnology from FH Campus Wien | University of Applied Sciences, which they completed in 2017. Currently, they are pursuing an MBA in Health Tech Management from Fachhochschule Technikum Wien, which they are expected to complete in 2024. Additionally, they have obtained several certifications, including Technical Documentation for High-Risk AI Systems from Validate ML GmbH in 2021, Internal Auditor ISO 13485:2016 & EU MDR – Regulation (EU) 2017/745 from en.co.tec - Medizinprodukte-Consulting & Akademie in 2020, EU MDR 2017/745 & ISO 13485:2016 Delta Analysis from en.co.tec - Medizinprodukte-Consulting & Akademie in 2020, ISO 13485:2016 - Quality Management for Medical Devices from en.co.tec - Medizinprodukte-Consulting & Akademie in 2019, and Certified Internal Quality Auditor TÜV® from TÜV AUSTRIA Group in 2021.