Services

Services

Project management
Project review & planningIntellectual Property, (IP), analysis IP patent draftingCompetitive analysis Market researchClinical analysis Voice Of the Customer, (VOC), clinician feedback documentation Concept development Computer Aided Design, (CAD), based engineering solid models & prints 3D printed prototypingPrototype development Tolerance analysisFinite Element Analysis (FEA)Design simulationFormative & Summative testingBench & verification testingHuman factors & validation testingManufacturing process development Design For Manufacturability, (DFM)Design control documentation Design History File, (DHF), documentation Technical file documentation FDA 510k submission documentation Remediation documentation Legacy product design auditQuality Management System, (QMS), development Standard Operation Procedure, (SOP), drafting and review Work Instruction, (WI), drafting & review Material Review Board, (MRB), analysis Complaint investigation & analysis Infrastructure developmentTechnology seminarsEngineering resource development/training Other

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