Nila-Pia Rähle is supporting us with regulatory affairs and quality management related questions.

She has been working in medical devices for nearly 20 years, for both global players and start-ups and has broad experience along the whole value chain with a key focus on project management, regulatory affairs and quality management. She hold a master's degree in Biochemistry from ETH Zurich and a MBM from IE Business School in Madrid.

Areas of Expertise:
Start-Ups, Quality Management, Regulatory Affairs, ISO 13485, MDR, IVDR, Internal Audits, Supplier Audits, Technical Documentation for medical devices of all classes, Supplier Management, Business Development / Contract Negotiations, General Management