Christina Degen-Wendlinger

Christina Degen has been working in quality management and regulatory affairs in MedTech since 2008. In this role, she has supported medical devices in classes IIa to III, as well as in vitro diagnostic devices, throughout their entire product lifecycle, from development to global approval.

She has held various roles at companies such as Sequana Medical, Biovotion Biofourmis, Axon Lab and Enclustra. Since 2022, she has been a Senior Consultant at inmedis AG, where she assists clients with regulatory and quality-related matters.

During this time, she provided regulatory support for development projects, prepared technical documentation and implemented international approval procedures, including FDA 510(k) applications. She was also responsible for establishing and further developing quality management systems in accordance with ISO 13485, as well as overseeing their successful certification and audit support.

• Regulatory affairs and international approvals, including FDA 510(k)
• Technical documentation and product approval for medical devices and IVDs
• Quality management systems in accordance with ISO 13485
• Development and implementation of compliance and regulatory processes
• Labelling and regulatory requirements for international markets