Head of Global Operations and Principal Consultant
Principal Consultant
Stephanie is part of Qserve's Regulatory Non-Active Devices Group, her area of expertise is: PMS Vigilance. She has, however, a broad experience in Regulatory Affairs as well as Quality Management Systems.
Within Qserve Stephanie combines strong experience in Regulatory Affairs and Quality Management with a pragmatic, pro-active and result-driven approach. She uses her Project Management capabilities to interface with management, sales teams, sales channels, supply chain. She has dealt with supporting teams to certification and global registration of non-active devices and with the setup of Quality Management Systems compliant with the legislation different regions of the world.
Prior to Qserve, Stephanie was Manager Regulatory Affairs & Quality Assurance EMEA at an international company in Orthopedics devices. She also worked for a Notified Body as lead auditor medical devices. Stephanie has over 12 years’ experience in Quality Management Systems (e.g. ISO 13485, FDA CFR21 Quality System Regulations). She holds a Master degree in Human Movement Science (MSc).
She has been responsible for the management of Regulatory submissions for different regions in the world (e.g. EU, Middle East, Russia). She has solid knowledge of global medical device requirements in relation to new product developments, post-market surveillance and timely marketability.