Niels Festjens
Chief Technology Officer at QualiFest Consultancy
Sint-Katelijne-Waver, Antwerp, Belgium
Summary
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Senior🎓
Top SchoolNiels Festjens is a Chief Technology Officer and Quality Management System architect with 11 years of experience designing and implementing regulatory and quality systems for medical devices across software, implants, surgical instruments, additive manufacturing and AI-driven products. He specializes in tailoring ISO 13485-compliant processes and EU/US regulatory strategies (CE, FDA 510(k) and inspections) to company culture to accelerate product development and market launch timelines. As principal consultant at QualiFest and CTO of DEO.care, he blends hands-on implementation with strategic oversight, having led quality functions at Materialise and supported patient-specific and sterile device programs. Notably, he brings a rare combination of engineering training and practical incident management experience, enabling him to translate complex technical requirements into auditable, launch-ready systems.
11 years of coding experience
11 years of employment as a software developer
Master Electronical Engineering, Master Electronical Engineering at Erasmushogeschool BrusselGediplomeerde in de Aanvullende Studies (GAS) van de toegepaste informatica Informatics, Gediplomeerde in de Aanvullende Studies (GAS) van de toegepaste informatica Informatics at Vrije Universiteit BrusselHHC
English, Dutch, French, German
Stackoverflow
141reputation
26kreached
1answer
0questions
Github Skills (33)
html-to-pdf10
wkhtmltopdf10
pdf9
pdf-generation9
angular8
react8
typescript8
javascript8
nodejs8
html6
selector6
redmine6
file-operations6
jquery6
webkit6
Programming languages (4)
Github contributions (5)
NielsFestjens/Accountancy
Aug 2017 - May 2024
An accountancy application
Contributions:40 pushes, 1 branch in 6 years 9 months
djangoaccountancy
Winnrman/An-Empty-World
Jan 2022 - Feb 2022
Idle Game Based on A Dark Room with bits of NGU Idle and others mixed in.
Contributions:64 commits, 44 PRs, 2 comments in 1 month
incrementalgameidleidle-gameroom
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