Ulla Gertig

Ulla Gertig currently serves as a Senior Consultant in Regulatory Affairs at AKRA TEAM GmbH, where she leverages her extensive expertise to support medical device companies in achieving compliance and securing CE Mark certification. With over six years of dedicated experience in regulatory affairs and nine years in clinical writing, Ulla brings a comprehensive understanding of the intricacies involved in bringing innovative medical devices to market. Her role involves conducting thorough assessments of technical documentation, identifying regulatory gaps, and ensuring that all documentation aligns with the latest EU MDR and MDR requirements.

Ulla’s expertise extends to performing detailed literature searches and clinical evaluations, which are critical components in demonstrating device safety and efficacy. She specializes in clinical writing and literature review, providing clear, scientifically robust documentation that supports regulatory submissions. Her proficiency in NB communication ensures effective dialogue with notified bodies, streamlining the approval process. Ulla’s background in scientific research, particularly in inflammation, neurodegenerative diseases, and Alzheimer’s disease, enhances her ability to evaluate clinical data with precision and insight.

At AKRA TEAM GmbH, she is known for her strategic approach to regulatory consulting, helping clients navigate complex compliance landscapes while optimizing their documentation processes. Her skills in clinical evaluation, literature research, and regulatory consulting make her a valuable partner for medical device innovators seeking to bring safe, compliant products to global markets. Ulla’s commitment to excellence and her deep industry knowledge position her as a trusted advisor in the evolving field of medical device regulation.