jnm22

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 ...

In forum Organizational Development in Device Companies

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...

In forum Organizational Development in Device Companies

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...

In forum Organizational Development in Device Companies

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
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