Johann Delchmann, B.Eng.Medical Device Specialist

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.

Expertise:

  • Peritoneal dialyse
  • Neurology
  • Epilepsy
  • Migraine
  • Risk management for medical devices acc. to ISO 14971
  • Quality Management Systems acc. to ISO 13485
  • Injection Systems
  • Technical Documentation
  • Combination Products