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Speaker: Phil

During my studies I had my first contact with Regulatory Affairs. After a steep learning curve and several years of daily work with standards and laws, I am able to explain a bit of the everyday life.

I studied economic computer science and always tried to work as a developer during my studies. The company I was in then started to develop medical products. At some point, we were faced with the question "What do we actually have to do in order to sell our product at all? Since my "economic background" came closest to our problem of all people, that was my task. So I fell into the regulatory pot.

I work as Regulatory Affairs Manager for several years now. My tasks include requirements management, technical documentation, risk analysis, usability, market launch, market monitoring and feedback. The tasks cover the entire product life cycle.

It is interesting to see how the medical device market is becoming more and more interesting. This applies equally to start-ups and tech companies. The software part in the products is getting bigger and bigger and now the authorities and companies have to deal with it.