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 company’s overall mission. If a mid-size company with ...

The company’s SOPs in Quality Control (QC) should ensure meeting all regulatory requirements for their medical products, and should include preventative actions to ensure avoidance of receiving a Form...

I definitely agree with your response alexandrabuga. From a global standpoint, both 21 CFR 820 and ISO 13485 are guidelines for medical device companies to use for not only documenting, but ensuring p...

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 training sessions for audit preparation that is mandato...

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 need for the study, developing the schedule, budget,...

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 from our classmates, animal testing is bottom line ...

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 of MS versus PhD. I currently am working towards a...

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 opportunity and to find a semester project research o...

I agree with previously made points. Design changes can affect several parts of the product and can create several moving parts that the project manager and team need to be aware of. First I would agr...

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 product in the validation and post validation stages ...

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 organize and plan the steps it takes to develop new desi...

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. Currently, I am working on a project that hasn't complete...

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 had a kick off meeting to introduce the new project ...

I agree, Six Sigma is a very powerful tool for project management. The methodology of Six Sigma is DMAIC: define, measure, analyze, improve/implement, and control. Define the problem and relate it to ...

Engineering change orders provide documentation of corrective actions for faulty components, end of life components, or more efficient components in a medical product, ultimately increasing the produc...