Monika KrasniqiConsultant and Project Manager

Monika is a specialist for design control of combination products and medical devices. As a medical engineer, she has gained experience during specific projects with different industry partners of medical devices at the university. Her analytical mindset enables her to get to the bottom of a problem and design value-added solution. In addition to biology and physiology, she also has expertise in regulatory affairs, quality management (ISO 13485), risk management (ISO 14971), and usability engineering (ISO 62366).

Moreover, she is familiar with the overall design control process and supports well-know pharmaceutical and medical technology companies in terms of creating technical documentation and also maintaining the design history file with respect to combination products.

Expertise

  • Pre-Filled Syringe
  • Auto-Injectors
  • On-body devices
  • Combination Products
  • Regulatory Affairs
  • Risk Management 
  • Usability Engineering
  • Design Control
  • Technical Documentation
  • Change Control Management
  • Project Management Activities