Johann is a medical device specialist with experience in mid-size and global device and biotech organizations in the field development and project management for combination products and class IIa medical devices.
He has a special focus on requirements engineering processes, design verification, risk management, lifecycle management tools (Matrix Requirements, Polarion®) as well as device documentation according to ISO 13485 and CFR 820 requirements.
- Peritoneal dialyse
- Risk management for medical devices acc. to ISO 14971
- Quality Management Systems acc. to ISO 13485
- Injection Systems
- Technical Documentation
- Combination Products