Karin Schwenoha

I’m a Senior IVDR and Regulatory Affairs professional with more than 20 years of experience in laboratory diagnostics, conformity assessment, quality management, and regulatory governance within the IVD sector. I bring extensive expertise in IVDR, including technical documentation review, performance evaluation, and risk management, grounded in hands-on laboratory experience.

In my recent roles as an Independent IVDR Product Reviewer and Senior Expert Advisor/IVDR Product Reviewer, I assess IVD device technical documentation and performance evaluation reports under IVDR—evaluating risk management documentation and clinical evidence while contributing to conformity assessment activities and regulatory decision-making. I’m especially focused on translating complex regulatory and scientific requirements into practical and sustainable solutions for manufacturers, laboratories, and notified body environments.

Previously, as Head of IVD / Head of Competence Management, I coordinated IVDR conformity assessment activities and multidisciplinary expert teams, communicated regulatory findings to manufacturers and customers, and led scientific review and interpretation of clinical and performance data. I also strengthen my regulatory impact through ISO 13485 and MDSAP audit experience, plus academic leadership as a Senior Lecturer in laboratory medicine, clinical diagnostics, and risk management.