Meet Dr. Martina Zell
Founder, CEO & Principal Consultant
Dr. Martina Zell is the founder and principal consultant of Zell Medical Consulting. With a rigorous scientific background and deep, specialized expertise in the medical device industry, she is dedicated to helping innovators navigate the complex and challenging path to market.
Martina believes in a direct, hands-on partnership model. She works side-by-side with her clients, providing the strategic guidance and practical support needed to ensure robust regulatory compliance without creating unnecessary overhead. Her passion lies in translating complex regulatory requirements into clear, actionable strategies, turning potential obstacles into business advantages for her clients.
By focusing on pragmatic solutions tailored for startups and SMEs, Martina helps companies build the essential frameworks for quality and safety, enabling them to launch their products with confidence and integrity.
Martina believes in a direct, hands-on partnership model. She works side-by-side with her clients, providing the strategic guidance and practical support needed to ensure robust regulatory compliance without creating unnecessary overhead. Her passion lies in translating complex regulatory requirements into clear, actionable strategies, turning potential obstacles into business advantages for her clients.
By focusing on pragmatic solutions tailored for startups and SMEs, Martina helps companies build the essential frameworks for quality and safety, enabling them to launch their products with confidence and integrity.
Areas of Expertise
- Regulatory Affairs (EU MDR & IVDR, FDA)
- Clinical Affairs & Clinical Evaluation (CER)
- Quality Management Systems (ISO 13485, 21 CFR 820)
- Software as a Medical Device (SaMD) & IEC 62304)
- Digital Health & AI Compliance
- Risk Management (ISO 14971)
Credentials & Professional Development
- Ph.D., Natural Sciences
- Certified Data Protection Officer
Meet Chiara Fliegner
Regulatory and Compliance Consultant
Chiara Fliegner is a Regulatory and Compliance Consultant at Zell Medical Consulting. She serves as the crucial interface between technical implementation and regulatory requirements, ensuring a seamless translation between the two worlds. Her practical experience in programming and penetration testing allows her to communicate effectively with development teams, ensuring that regulatory needs are understood and implemented correctly from the ground up.
She specializes in guiding clients through the complexities of data protection, cybersecurity, and IT compliance within the MedTech landscape.
She specializes in guiding clients through the complexities of data protection, cybersecurity, and IT compliance within the MedTech landscape.
Areas of Expertise
- Data Protection & GDPR Compliance: Advising on all aspects of GDPR compliance for medical devices and DiGAs, providing expert guidance on Data Protection Impact Assessments (DPIA), privacy policies (DSE), records of processing activities (VVT), and the compliant handling of data processing agreements (AVV).
- Cybersecurity & IT Risk Management: Consulting on the creation of comprehensive cybersecurity documentation for medical products and providing strategic advice on risk modeling and management.
- IT Compliance & Software Validation: Guiding clients in the implementation of IT security standards, advising on the structure and content of software validation plans and reports, and consulting on compliant configuration management, including the handling of SOUP lists.
Credentials & Professional Development
- Certified Data Protection Officer (TÜV SÜD), since 2021
- IT Specialist for Data and Process Analysis, certified by the German Chamber of Industry and Commerce (IHK)
- 5 Years of Professional Experience in Data Protection & GDPR Compliance and Cybersecurity & IT Risk Management.