Yoann Buisson, Phd Email & Phone Number

Bournemouth, Gb

London, Gb

London, Gb

Accreditation managementGlobal regulation systems implementation/integration for Notified Body, Approved Body and QMS schemes (ISO 13485 schemes, MDR, IVDR, MDD, MDSAP)Notified Body Software Working Group - Implementation of NB & AB policies and processes for medical device software & SaMDSet up of ISO 42001 Artificial Intelligence certification bodyManagement of regulator auditsGlobal auditor update trainingGlobal leadership for QMS and software

London, Gb

UKAS & RVA ISO 13485 Global Scheme Manager at BSIImplementation/Integration of Notified Body and Global QMS Scheme Processes (ISO 13485 schemes, MDR, IVDR, MDD, MDSAP)Notified Body Software Working Group - Implementation NB assessment policies and process for medical device software & SaMD

London, Gb

Delivery of assessments, assessor training, public training courses

Charlotte, North Carolina, Us

Expanding CEE and Emerging Market RegistrationsVigilance and PMSERP System Implementation for EU, Middle East & Africa

 Collaborative clinical study manager and medical device development consultant Design & Quality Management Planning; EMA, FDA, emerging markets regulatory submissions Medical science advisor

Bracknell, Berkshire, Gb

 Industry Postdoc responsible for setting up, running and reporting on clinical trials, product development, building the CE technical file (reports/CER/systematic reviews) & submissions (510k) to international regulatory authorities (CE, FDA, TGA) for Actegy Ltd medical devices. Scientific advisor for legal/regulatory affairs. Managing studies of non-invasive blood flow and blood chemistry measurements using near-infrared spectroscopy, laser Doppler flowmetry and Doppler ultrasound Masters level research project supervision.

London, Gb

Set-up and completed a set of clinical trials examining (1) the clinical diagnostic potential of brain stimulation in spinal pathology and (2) to measure the impact of spinal surgery and conservative treatments (i.e. corticosteroid injections) on neuroplastic changes in the motor cortex induced by spinal pathology (these involved up to 82 patients & participants followed up for up to 68 weeks).  Developed a series of mutually compatible programs for the signal analysis of multi-channel cortical motor evoked potentials.The studies led to an MRC grant, new avenues of investigation to improve functional outcomes from spinal surgery and had wider implications in the treatment of MSK chronic pain conditions.

London, Gb

Contract application programming and hardware implementation for a clinically deployable peripheral nerve stimulation interface for the automatic calculation of sensory perceptual threshold in assessment of spinal cord injury (funded by the Christopher Reeves Foundation).

London, Gb

Set-up and completed a clinical study laying out a new experimental technique to examine vestibulo-corticospinal (central balance-motor) interactions in man, using cortical stimulation and caloric irrigation (See Publications).

Glasgow, Gb

Msc R&D project (with distinction): portable device for the non-invasive & continuous transcutaneous extraction and monitoring of glucose & lactate by reverse iontophoresis (for diabetes and intensive care applications). Protocols were tested in vitro and in vivo and results were published (See Publications).

Doctor Of Philosophy (Ph.D.), Medicine, Neurophysiology

Master'S Degree, Bioengineering And Biomedical Engineering

Bachelor'S Degree, Electrical And Electronics Engineering

Education record