I think when a company is selecting between corporation (Inc) or limited liability company (LLC), it needs to weigh the pros and cons against the comp...
The company’s SOPs in Quality Control (QC) should ensure meeting all regulatory requirements for their medical products, and should include preventati...
I definitely agree with your response alexandrabuga. From a global standpoint, both 21 CFR 820 and ISO 13485 are guidelines for medical device compani...
I have participated in 1 unannounced FDA audit and 1 MDSAP mock audit in the medical industry before. Prior to each audit, there are a series of train...
Like any other project, the Project Manager is fully involved in pre-clinical studies. PMs are involved in the preparation of the business case and ne...
This is a very difficult topic because it is an opinionated debate between necessity versus ethics. And it appears from the majority of the feedback f...
Great topic!! I wish there were more responses because I am too (not to sound repetitive) very curious about this. I have been torn with the decision ...
I have worked in the medical industry for about a year and a half and would recommend students to really take the time to find an internship/co-op opp...
I agree with previously made points. Design changes can affect several parts of the product and can create several moving parts that the project manag...
I haven't personally worked with an ECO, but I have seen plenty of them in my current position. I have only noticed our company producing ECOs for pro...
I absolutely love and live by Gantt charts. In my undergraduate studies, we would use MS Project Gantt charts and Visio high-level schedules to organi...
I agree. From what I have seen in the medical industry, when a design change is necessary the steps taken depends on the stage of the project. Current...
I have also experienced this in the industry in one of the projects I have been a part of. There was a change in PM due to resource constraints. We ha...
I agree, Six Sigma is a very powerful tool for project management. The methodology of Six Sigma is DMAIC: define, measure, analyze, improve/implement,...
Engineering change orders provide documentation of corrective actions for faulty components, end of life components, or more efficient components in a...