The quality enthusiast
"In my projects, the quality of processes and products must withstand even very critical questions."
Sebastian Kern leads the Medical Devices team at Method Park. With high quality awareness, strong leadership skills and a passion for technical refinements, he works on software development for future-oriented medical devices together with his team.
Particularly in the healthcare industry, medical regulations play an essential role in ensuring high quality: Whether IEC 62304, ISO 14971, the medical device regulations or directives - Sebastian Kern is enthusiastic about all of them. This makes him an expert in medical regulatory affairs for Method Park customers.
Among others, he contributed this know-how to a project for the automatic calculation of insulin dosages. One task particularly inspired him in this project: the development of a prototype that evaluates the control algorithm and adjusts the rules based on real data.
Sebastian Kern is a member of the VDI's Medical SPICE guidelines committee and passes on his expertise in quality assurance through software testing or the introduction of agile methods in courses and training sessions, conference presentations, and technical articles.
- ISTQB® Certified Tester and Agile Tester
- CPMS Certified Professional for Medical Software
- TÜV Internal Auditor Medical Device Industry
- intacs™ Provisional Assessor
- ECQA® Certified Software Process Improvement Manager
- Certified Scrum Master
He leads the following courses:
- ISTQB® Certified Tester Foundation Level
- ISTQB® Certified Tester Foundation Level - Agile Extension