Achievements & Feedbacks
Technical Documentation Support
« Richard has succeeded in establishing a strong relationship based on trust, which is essential to our commitments to the Notified Body (ensuring that technical documentation meets the state-of-the-art standards of the medical industry and that deadlines are met to ensure optimal integration into a successful CE marking project). »
Technical Director – Manufacturer of Implantable Orthopedic Devices
Spine – Innovative lumbar spinal fixation
Simulation on lumbar spine representative of the vertebral geometry (model from real subjects: Bpath license / Institute of Human Biomechanics Georges Charpak, ENSAM, Paris 13, France)
Hip – Study of a ‘smooth’ cup holder
Knee – Study of a ligamentous fixation onto an interference screw
Spine – Translaminar Facet Fixation system [TFFS]
Knee – All Ceramic knee prosthesis system definition
« Your work was flawless in both areas: creating the drawings of the prosthesis as well as the implementation of the risk analysis. »
Laurent Sedel – Professor Emeritus, former head of the orthopedic surgery department at Lariboisière (APHP)
Special Processes:
– Rough Ti plasma projection process validation
– Laser marking process validation protocol
External PRRC
« A very strong understanding of design activities, production operations, and clinical demonstrations in the field of orthopedic implants, along with proficiency in the associated tools to effectively demonstrate compliance with European regulations. This expertise and professionalism are highly valued, allowing to entrust Richard with the role of external PRRC with full confidence ».
Regulatory Affairs Director for a manufacturer of implantable devices
Interim
Role of R&D/RA Director during maternity leave