Andreas Kalchschmid-Lehmann

Andreas Kalchschmid-Lehmann, born in 1982 in Germany, is a guitarist in a heavy metal band, a molecular biologist, and an enthusiastic advocate of good quality management systems.

During his career as Technical Assistant, Quality Manager and Lead Auditor for the MDSAP Auditing Organization and Notified Body TÜV SÜD, he had deep insights into the functioning of small and large companies worldwide, thus learning by practical example what makes a good and functioning process and how to set up QM systems in a way that benefits both employees and companies instead of hindering them.

In 2020, he was the lead auditor for the world's first EU certificate issued under the In Vitro Diagnostics Regulation (EU) 2017/746 (IVDR).

He currently works as a consultant for the Johner Institute, where he supports all stakeholders in the medical device industry on all topics related to regulatory affairs and quality management systems.