André von Malotki

André von Malotki has over 12 years of experience in the medical device industry and has worked predominantly in regulatory affairs. He has handled a wide range of registrations worldwide, particularly in the EU and the U.S.

André has led projects related to labeling requirements, including UDI, over the course of his career and is an NSF-qualified trainer. He has also set up an internal team at NSF that performs regulatory affairs activities for clients.

André studied medical engineering at HAW University of Applied Science in Hamburg, Germany, and has completed several additional training programs in order to optimize our service portfolio and meet clients’ needs.

Areas of Expertise:

• Regulatory Affairs
• Technical Documentation
• EU Medical Device Regulation (MDR)
• Quality Management Systems
• Unique Device Identification
• Labeling
• Moderation of Teams
• Training Instructor