Forum Replies Created
RE: Discussion Topic: Easier regulatory in EU? Hey I agree that this is true but it also makes me worry about products coming from the EU. Due to the fact that the process is quicker and easier are product equally safe? I can't imagine shortened/n... |
In forum EU Regulatory Basics |
8 years ago |
RE: Discussion Topic: Your Field or Profession Hey gh56, There is a graduate course on BioMEMs with Perez and it is very interesting where we read plenty of articles about the current practices. Yes I have been fascinated by 3D printing for a long... |
In forum Introduction to Advanced Medical Device Development |
8 years ago |
RE: Discussion Topic: Your Field or Profession Hi Andrew, Yes this is a very common trend, that depends on company size but. My company is fortunate enough to have comparative medicine onsite so they do a lot of our pre-clinical animal studies but... |
In forum Introduction to Advanced Medical Device Development |
8 years ago |
RE: Discussion Topic: Your Field or Profession Hey, I also work in the pharmaceutical industry but I try to keep my self up to date with 3D printing for regenerative medicine along with BioMEMS. These two trends are huge and I personally think rea... |
In forum Introduction to Advanced Medical Device Development |
8 years ago |
RE: Restrictions for physician's gifts My company also has rules against gift giving for protection against lawsuits. Personally I think instead of restricting the process they should just ban it. Doctors shouldn't have to be bought and sh... |
In forum Consultants and Legal Basics |
9 years ago |
RE: Written Agreement v/s Verbal Agreement I find that to be very surprising as I did not know verbal agreements were something that is acknowledged by the law. The quote above says "as long as there is enough evidence" but what is enough evid... |
In forum Consultants and Legal Basics |
9 years ago |
RE: Discussion Topic: Course conclusion and impressions I thought this course was very useful as well and I am already working in industry. I liked that you showed us every division within medical devices and their importance. Honestly I wish I took it bef... |
In forum Consultants and Legal Basics |
9 years ago |
RE: Forming a Project Team As a lot of people have mentioned choosing your team members is not that realistic in the real world. People are just assigned projects based on their role. It would be best and helpful if the person ... |
9 years ago | |
RE: Organization types of medical devices? Hey, Thanks for the link. If I were to start my own company I would go for a matrix organiation as it makes the most sense to me. I think the combination of functional organziation and project base di... |
9 years ago | |
RE: Discussion Topic: Your organizational type I am not sure what type of organization my job is. It seems to be a mixture of functional and matrix. Project managers are assigned to a project from their manager and the project can expand to differ... |
9 years ago | |
Risk management and Labels As I was going through the lecture I realized a lot of risk management is done before the product hits the market or done on the company side. This made me think of labels and instructions for use. I ... |
In forum Risk Analysis for Medical Devices |
9 years ago |
RE: Expense of Regulations Wow, that is very interesting. I didn't know that you had to pay to view standards but it makes sense. As Kaitlin said they are essentially doing you a service by helping you stay in compliance. It is... |
In forum Risk Analysis for Medical Devices |
9 years ago |
RE: Risk analysis in real company In pharma risk analysis deals with biologics so all suggestions and concerns from the team are used to create the animal study. For example we recently were working on a drug and we feared it would ha... |
In forum Risk Analysis for Medical Devices |
9 years ago |
RE: Factors to Consider While making Gantt Chart I think mistakes should be taken into consideration when making a gantt chart.There should be room for error for materials and even in the lab. There should be a soft deadline and a hard one with week... |
In forum Introduction to Design Controls |
9 years ago |
RE: Design Transfer I think there are pros and cons to outsourcing and it is dependent on your device and companies. Some companies lack infrastructure, or manpower and have to outsrouce others don't and keep it inhouse.... |
In forum Introduction to Design Controls |
9 years ago |