As learnt from the this weeks lecture the items that affects the quality are listed in presentation of this week like : Money, Management Commitment, Organization-Job Design-Human Factors, Management of Risks, QC & Release Process,Training, Maintenance, Preventive controls an many more.

So I would say a bit about Risk Management: Definition of risk according to medical device as per ISO14971 is probablity of occurrence of that harm and severity of that harm. Though nothing is full proof but essential thing is identify, evaluate and analyze and mitigate main product issues. I think we should think from patients point of view

So students working in industry may have more practical knowledge about these factors so share your experience and knowledge regarding this.