Dr. Kristin Mertins, Senior Clinical Affairs Manager

Dr. Kristin Mertins combines scientific excellence, regulatory expertise, and practice-oriented knowledge transfer in the field of medical technology. As an experienced Regulatory & Clinical Affairs Manager, she has more than 15 years of professional experience at the intersection of medical devices, the pharmaceutical industry, and cutting-edge academic research. Since 2019, she has been advising companies at qtec Services on clinical and regulatory matters, with a particular focus on the requirements of the European Medical Device Regulation (MDR).

As a recognized expert in Clinical Evaluation and Medical Writing, she is responsible for the preparation of compliant clinical evaluations and systematically conducted literature searches. Another key focus of her work is the strategic design and operational implementation of post-market processes, including Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF). Her profound expertise, gained through positions as a Medical Writer at a Contract Research Organization (CRO), in chemical-pharmaceutical project coordination, and as a Postdoctoral Researcher (including at ETH Zurich and Henkel), makes her a sought-after specialist for all phases of the medical device lifecycle.

At the qtec Academy, she shares her expertise with medical device manufacturers, pharmaceutical companies, regulatory authorities, and notified bodies. Her focus lies on clinical evaluation and structured literature searches, always with the goal of making complex regulatory requirements practical, understandable, and directly applicable.

What matters most to her as a speaker:
"I want to provide participants with new knowledge and practical tips to help them implement the many MDR requirements effectively within their organizations."