Professional Overview
Rudolf Wagner is a seasoned expert in the fields of SaMD (Software as a Medical Device), AI in Healthcare, and Digital Health. He currently serves as the Founder and Consultant at ADHOCON™️, a contract legal manufacturer specializing in these domains. With his extensive industry knowledge and regulatory expertise, Rudolf plays a pivotal role in shaping the future of digital healthcare technologies.
Experience Summary
Current Role
As the Founder and Consultant at ADHOCON™️, Rudolf is responsible for guiding clients through the complex landscape of SaMD and AI-based healthcare solutions. He leverages his deep understanding of regulatory requirements and industry best practices to ensure that innovative digital health technologies meet the highest standards of safety and efficacy.
In addition to his role at ADHOCON™️, Rudolf holds several notable positions that showcase his influence and impact within the industry. He currently serves as the Head of Regulatory Affairs at Siemens Healthineers, where he oversees the development and implementation of regulatory strategies for the company's medical devices and digital health offerings.
Furthermore, Rudolf is a member of the EU General-Purpose AI Code of Practice Working Group at the EU AI Office, contributing his expertise to the establishment of ethical and responsible guidelines for the deployment of AI in various sectors, including healthcare.
Career Progression
Prior to his current roles, Rudolf has held leadership positions in the medical technology industry, where he has consistently demonstrated his ability to navigate complex regulatory landscapes and drive innovation. His deep understanding of the evolving regulatory framework and his commitment to patient safety have been instrumental in shaping the development and commercialization of cutting-edge digital health solutions.
Academic Background
Rudolf holds a strong academic foundation, with his highest level of education being a degree in a relevant field. His specialized knowledge and expertise in areas such as AI, medical devices, and IVDs (In Vitro Diagnostics) have been recognized through his certification as an EN ISO 17024 Expert Witness, allowing him to provide authoritative testimony in legal proceedings related to these domains.
Areas of Expertise
- Regulatory Affairs and Compliance for SaMD, AI-based Healthcare Solutions, and Medical Devices
- Navigating the complex regulatory landscape in the European Union and global markets
- Ensuring the safety, efficacy, and ethical deployment of digital health technologies
- Bridging the gap between technological innovation and regulatory requirements
- Providing expert guidance and strategic insights to clients and industry stakeholders
Professional Impact
Throughout his career, Rudolf has made significant contributions to the advancement of digital health technologies. He has been actively involved in shaping industry standards and best practices, as evidenced by his membership in the EU General-Purpose AI Code of Practice Working Group.
Additionally, Rudolf's role as a Board of Advisors member at Kare ai, a leading AI-driven healthcare company, demonstrates his impact on the strategic direction and development of innovative digital health solutions.
Conclusion
With his extensive experience, deep industry knowledge, and a proven track record of success, Rudolf Wagner is a respected expert in the fields of SaMD, AI in Healthcare, and Digital Health. His commitment to regulatory compliance, patient safety, and ethical innovation positions him as a valuable asset to both clients and industry stakeholders as they navigate the ever-evolving digital health landscape.
