Ulrich Schwanke’s passion is regulatory affairs for medical devices. 

As a trained medical doctor with clinical knowledge, Ulrich has more than 20 years of experience in consulting, gained in more than 100 projects in the healthcare sector. In 2013 he founded his own company “FAQ Consulting“, providing hands-on support for medical device manufacturers in obtaining product approval (CE conformity) in Europe. He is offering a wide range of services from the approval to the successful market entry for medical devices. 

Ulrich is the Swiss Army knife for start-ups, small, and medium-sized enterprises. He offers practical solutions for technical documentation, implementation of QMS according to EN ISO 13485, and compliance with the requirements of MDR 2017/745. His daily bread includes the development and implementation of processes, standards-compliant documentation, complaint and CAPA procedures, and process validations. For Ulrich as a clinical expert, the preparation of clinical evaluations is a primary focus.