Research On Orthopedic Implant Medical Device Design And Development Project Risk Management

In recent years,the medical device industry has developed rapidly on a global scale,especially with the aging of the population,the demand for orthopedic implants is growing more and more.As Class III medical device,orthopedic implants have the most stringent regulatory requirements,in order to ensure the safety and effectiveness of the product,it is very important to implement the risk management on the orthopedic implant design and development projects.This paper takes Class ? orthopedic implant design and development project risk management as the research object and S company biological femoral stem design and development project as the specific case,through establishing the project risk management theory framework,theory guides practice.Firstly,this paper developed a risk management plan of the biological femoral stem project.Then,it identified the project risks via WBS-RBS method.Based on this,this paper used AHP method to analyze the project risk qualitatively and quantitatively,and obtained the relative weight of the project risks accordingly.Finally,this paper developed the corresponding risk management strategies and measures,and implemented risk management monitoring as required.The successful completion of the biological femoral stem design and development project proves the validity of the project risk management model constructed in this paper,which has certain reference value and guiding significance for the risk management of other medical device design and development projects.