Medical Engineering & Quality Management
Benjamin Alain Zeliska
Bridging the gap between technical development and regulatory compliance. Pragmatic solutions for complex medical device challenges.
System Audit Readiness
Status: Secure
Active: MAS Regulatory Affairs & Quality Management (Uni Bern)
Infrastructure: FDA 510(k) Track Enabled
"Engineering compliant pathways for complex medical devices."
ISO 13485 // MDR // ISO 14971
Professional Experience & Education
Ongoing
MAS in Regulatory Affairs and Quality Management
University of Bern
Quality Management Specialist
Hirslanden Group
Research & Development Engineer
Ardo medical AG
Bachelor of Science in Medical Engineering
Academic Education
Apprenticeship as Automotive Mechatronics Technician EFZ
Technical Foundation Training
MedTech Regulatory Skills
Specialized in critical regulatory standards, global submission pathways, and quality management systems for the medical device industry:
MDR 2017/745 (EU)
FDA 510(k) Submission
SN EN ISO 13485
SN EN ISO 14971
SN EN ISO 9001
21 CFR Part 820
Facing Regulatory Bottlenecks?
Let's analyze your technical or quality-related issues directly and straightforwardly.
Resolve Bottleneck