To make sure that medical devices are safe in every aspect, the US Food and Drug Administration (FDA) regularly inspects manufacturers of those devices, and thus they do with hearing aid manufacturers. Recently, FDA inspection were successfully completed in our offices in Singapore and Minneapolis, marking our third and fourth successful FDA examination within three months.
To achieve these impressive results, that make us very happy, cross-functional colleagues from different departments in Germany, Singapore, USA, China and Poland have been working together.
Jan Knittel, Head of Quality Systems at Sivantos, said: “This time, documents dating from 2016 were reviewed by the FDA inspector and the team provided approximately 5,000 pages of records, evidence and procedures.” The main result? We were told that our Quality Management System is in a very good shape. Since the quality system is of course a strategic key piece of our business landscape, we are more than happy about the outcome.
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