Clément David

Development of implants and instruments intended for the treatment of spinal pathologies, in accordance with the regulations (MDR and FDA) and applicable standards for medical devices Approach and ranges concerned • Open and mini invasive surgery • Implants and instruments for thoraco - lumbar system and cervical – thoracic junction R&D Development • Concept and technical solutions research • Product design on SolidWorks, development of industrial drawings • Integration of the 3D files and drawings into the Product Data Management (PDM) database • Prototypes’ production for practical Labs and mechanical tests to verify the functionality and the mechanical resistance of the products • Redaction of experimental protocols, tests protocols and test reports • Preparation of medical surveys and participation in practical Lab. Products industrialization • Sub-contractors sourcing • Optimisation of the design: to decrease the costs and to simplify the industrialization of the products • Manufacturing monitoring for the first batches. Project management of products integration • Integration and update of the drawings into the PDM database under Spineart requirements • Contribution to the DHF/DMR documentation (failure mode and effects analysis, engineering analysis, design verification & validation master plan,…) • Management of multidisciplinary project teams: R&D, Marketing, Quality and Regulatory, Manufacturing… • Agile project management (creation of work plan, deadline management, resources analysis…).

Design of the product: implants, instruments and boxes o Determination of engineering solution; o Development of implants and instruments associated; o Exchange information with suppliers about the manufacturing of the products designed; Design verification & validation o Manufacturing of prototypes for the verification and the validation of the products; o Creation of test protocols; o Setting up mechanical tests according to the protocols; o Results analysis and creation of test reports; o Collect the feedbacks of the end users (surgeons) during cadaver labs; o Analyse of these feedbacks and organization of a brainstorming with the team project about the potential improvements; Industrialization of the products o Research of subcontractors; o Manufacturing monitoring of implants and instruments designed; o Ensure the instruments’ reception (concerning the instruments designed): analysis of subcontractors’ documentation, dimensional control and functional analysis; Others o Update of the Device History Record (DHR) o Update of Design History File (DHF) o Update of Device Master Record (DMR) Results Achievement of all missions within the period prescribed by the project manager: • Deadline compliance of all missions • US Submission (510k) and European Submission (CE Marking) of all devices developed

R&D projects management of urological innovative products in accordance with the directives (MDR) and applicable standards for medical devices • Development of new products: from user needs’ analyses to design validation • Contribution to the DHF/DMR documentation • Management of multidisciplinary project teams: R&D, Marketing, Manufacturing… • Monitoring the realisation of the change control activities (technical support to the Change Control unit) • Agile project management (creation of work plan, deadline management, resources analysis…) • Post-Market Follow Up of the new products (complaints analysis).