Active Medical Devices Expert
Consultant
Introduction:
Bingshuo (Bing) joined Qserve in August 2022 as a Consultant and is based in Berlin. Bing’s background lies in the field of neurotechnology -- an intersection of neuroscience, technology, and health. He worked in the neurotech field for more than 7 years, during which he worked on various cutting-edge R&D projects including the development of a high channel-count wireless brain implant for vision restoration, the development of a wearable sensor for stress monitoring, as well as the development of novel non-invasive brain stimulation therapies for Parkinson’s disease. In addition to the R&D work as a scientist, Bing also has several years of experience in regulatory and quality affairs for a high-risk active implantable medical device at a neurotech startup, and experience in providing regulatory and operational advisory for startup and non-medical device companies to enter the medical device market.
About working in Qserve:
Rapid advance in technology brought us a slew of exciting opportunities to revolutionize the way we manage health and disease. Regulatory and quality is a critical component of this tech-driven health revolution. I am excited to be a member of the Qserve global team to assist medical device developers and manufacturers with their regulatory and quality challenges and be a catalyst for the exciting revolution!
Before Qserve:
Bing studied Psychology and Pre-clinical Medicine in the USA and received his M.S. and Ph.D. in Neuroscience from the Max Planck Society and the University of Tübingen in Germany. He completed his postdoctoral training at the Netherlands Institute of Neuroscience of the Dutch Royal Academy of Arts and Sciences in Amsterdam. During his Ph.D., Bing co-led a multidisciplinary team that engineered a ground-breaking technical solution for investigating in vivo neuronal activities evoked by transcranial magnetic stimulation (TMS). During his postdoc, Bing was part of a team that demonstrated the feasibility of using patterned high-density electrical brain stimulation to produce artificial sensory perception. Immediately prior to Qserve, Bing worked briefly at a large multinational management consulting firm where he advised various medical device and pharmaceutical clients.
The key expertise areas
- Deep scientific knowledge in neuroscience, neurology, psychiatry, and psychology
- Deep technical knowledge in neurotechnology; in particular, brain stimulation and brain-computer-interface
- Operational translation of regulatory and quality requirements
- Medical device design and development process management
- Medical device quality management system (ISO 13485) implementation
- Medical device risk management (ISO 14971) implementation
- Clinical investigation design and evidence evaluation
- Biostatistics
- Medical device technical documentation preparation
- Technical and scientific writing