Services

Project management
Project review & planning
Intellectual Property, (IP), analysis 
IP patent drafting
Competitive analysis 
Market research
Clinical analysis 
Voice Of the Customer, (VOC), clinician feedback documentation 
Concept development 
Computer Aided Design, (CAD), based engineering solid models & prints 
3D printed prototyping
Prototype development 
Tolerance analysis
Finite Element Analysis (FEA)
Design simulation
Formative & Summative testing
Bench & verification testing
Human factors & validation testing
Manufacturing 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 audit
Quality 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 development
Technology seminars
Engineering resource development/training 
Other

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