Quality Assurance and Regulatory Compliance

... has been working in the medical device industry for ten years.

Prior to working for next medical design, Daniela has held Quality Management positions with B.Braun, hemodialysis filters division, managing on site processes like CAPA, change control, document control, internal auditing, risk management and regulatory support for international submissions.

She has extensive knowledge and training in Quality Management Systems such as ISO 9001, ISO 13485 as well as 21 CFR 820.

Daniela is a native German and therefore provides support and service in German as well as English languages.

Daniela holds a Diplom-Ingenieur (FH) in biomedical engineering from the Anhalt University of Applied Sciences in Köthen, Germany.