Data-Driven MedTech Excellence: How Aesculap Integrates PLM & QMS for Optimized Processes

Mandy Blocher is a leader known for building and transforming Quality and Regulatory frameworks within the Medtech industry. As Head of PLM Digitalization & Regulatory Intelligence at Aesculap, a division of B. Braun, she is currently helping shape the strategic direction for the PLM program and Regulatory Intelligence initiatives. This strategic focus is underpinned by her experience as Head of Regulatory Intelligence at Aesculap (B. Braun), where she successfully established and maintained comprehensive processes for Regulatory Intelligence. Her earlier career includes impactful roles at smaller medtech companies providing spine implants, instruments and therapeutic UV-radiation devices, where she was responsible for QM system product registration and support of development projects.

Arielle Fakhraee is Director, MedTech Quality Strategy at Veeva Systems, specialising in the European MedTech market. Before this role, Arielle was a consultant focused on supporting MedTech companies on their journey as they lay the foundation for a harmonized Quality and Regulatory (QARA) function with streamlined processes, centralized data and structured content. She aims to help transform Quality and Regulatory from a tedious tick-box exercise to value-adding functions that directly contribute to the success of the organization through increased efficiencies and by accelerating speed to market. Compliance is simply one benefit of many.