Dr. Klaus Pollmeier has been active in the health sciences industry since 2007 and, since 2016, has been supporting companies worldwide as a qtec expert in regulatory matters related to the approval and market access of medical devices and in vitro diagnostic medical devices (IVDs).
As a trainer at the qtec Academy, he shares his extensive expertise with medical device manufacturers, pharmaceutical companies, regulatory authorities, and notified bodies. His training focuses include internal audits, supplier audits, risk management, process validation, and other key topics in Quality Management and Regulatory Affairs.
Thanks to his many years of experience across various business functions—including Product Management, Research and Development, Manufacturing, Quality Assurance (QA), Quality Control (QC), and Regulatory Affairs (RA)—Dr. Klaus Pollmeier has developed a profound understanding of the requirements and challenges throughout the entire product lifecycle. This enables him to effectively manage cross-functional interfaces and develop practical solutions while maintaining a clear focus on the complex regulatory requirements of the medical technology industry.
What matters most to him as a speaker: "Every client and every organization is unique and requires tailored solutions. In my training courses, I place special emphasis on understanding challenges from an individual perspective and exploring them collaboratively. This allows us to create a solution space filled with ideas and answers that are practical, sustainable, and capable of delivering real added value."
