Xiaoli Gou, MSc.
Xiaoli is part of the non-active Medical Device Regulatory Compliance team. Since January 2016 when she joined Qserve Group, she has gained hands-on experience in multinational compliance projects, including building technical dossiers, portfolio structuring, gap analysis, conducting a clinical evaluation, project coordination, and support. Her product portfolio experience spans from Class I wound care to Class III implantable devices.
Besides the European project, Xiaoli also is a Subject Matter Expert (SME) on the Chinese Medical Device Regulations. She has since then regularly authored blogs on various topics on the CFDA Regulations and supported clients with their product registration projects in China.
Xiaoli has a bachelor degree in biomedical engineering and a master degree in management in health and has worked in Singapore for a few years on an imaging diagnostics research project on the topic of liver fibrosis.
Xiaoli about working at Qserve:
“It’s been a great pleasure working with such a dynamic, dedicated, highly experienced and professional team at Qserve. With the ‘practical approach’ and patient safety in mind, together we produce customized solutions for our clients.”
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Document: China CFDA annual report on Medical Device Registration 2016