Mathias Eng

confinis ag
Hauptstrasse 16
CH- 3186 Düdingen

phone:	+41 26 494 8 494
mobile:	+41 76 515 5 074
email:	mathias.eng @confinis.ch
web:	www.confinis.ch

Profile

Topics

• quality management system (ISO 9001 / ISO 13485 / 21 CFR Part 820)
• software lifecycle process (IEC 62304)
• risk management (ISO 14971, ICH Q9,  ISO/DTR 80002)
• process validation / csv (GAMP4 / GAMP5, 21 CFR Part 11)
• usability engineering (IEC 62366)
• interdisciplinary project management (cGxP environment)
• lifecycle management
• premarket submissions for medical devices including software
• design history file remediation activities
• verification and validation activities (design and process)
• product development processes for medical devices (MDD, IVD and AIMD)
• electronics lifecycle processes
• mechanics lifecycle processes
• assessments and training
• auditing and gap analyses