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Forum Replies Created

Pros and Cons of the 3 Organizational Structures

This week's lecture describes that there are 3 different organizational structures: functional, projectized, and matrix organizations. Each organizational structure greatly impacts the way the company...

In forum Introduction to Project Management

7 years ago
RE: Experience with Design Control

I've practiced the most, if not all of the 9 design controls covered in this week's lecture in both school and work. For my undergrad senior capstone class we had to practice design controls over the ...

In forum Introduction to Project Management

7 years ago
Fitbit Medical Device?

I came across an article that discusses whether or not Fitbits should be classified as a medical device as per new FDA guidelines. Since it is not 100% clear as to what the FDA will regulate, it hinde...

In forum Introduction to Project Management

7 years ago
RE: Challenges in the Global Regulatory Environment

You bring up a great point - medical device regulation standards do not translate uniformly on a global scale. What may be deemed as a "safe" medical device in Europe for example may not pass US FDA r...

In forum Introduction to Project Management

7 years ago
FDA Regulations of Medical Device-Drug

This week's lecture got me thinking on how the FDA regulates a product that is both a medical device and a drug. There are clear and separate regulations for medical devices and drugs individually but...

In forum Introduction to Project Management

7 years ago
RE: Determining project priority

I think it's important that all projects are clearly prioritized and that each team member understands the level of priority each project holds. Being able to prioritize projects well ultimately impac...

In forum Introduction to Project Management

7 years ago
RE: Interpersonal skills vs technical knowledge

I believe the ratio of interpersonal skills to technical skills should be 50:50 in the medical device industry. There are instances where you can talk yourself up but you can only do it for so long un...

In forum Introduction to Project Management

7 years ago
RE: Discussion Topic: State of your Organization

I currently work at Ethicon as a R&D Engineer co-op. There are three industries that J&J spans which are consumer products, pharmaceutical products, and medical devices. Within these industrie...

In forum Introduction to Project Management

7 years ago
RE: Written Agreement v/s Verbal Agreement

Hi Nicole, You bring up an interesting point in that companies should be questioned if they are not willing to have legal counsel. When legal disputes arise, it forces the contractor to think twice a...

In forum Consultants and Legal Basics

8 years ago
RE: Restrictions for physician's gifts

This is all the more reason as to why being professional in business exchanges is important and should be reinforced. That is not to say table talk needs to be dry and fully factual. Various topics ca...

In forum Consultants and Legal Basics

8 years ago
RE: Consultants NDAs and CDAs

Hi Fady, The consultant that was hired at your company is in violation of an NDA or CDA for sure. It is quiet irresponsible of him to just copy the document from another company and not edit out the e...

In forum Consultants and Legal Basics

8 years ago
RE: Organizational Behavior Management

There definitely needs to be a balance when it comes to organizational behavior and I think a lot of people find it hard to draw the line between what is professional and what is too friendly. If empl...

In forum Organizational Development in Device Companies

8 years ago
RE: Organizational structure and Culture both leading to project success?

Interesting viewpoint here! Being part of an open and welcoming company culture motivates employees to perform better. Instead of fending for yourself, you are more inclined wanting to better your con...

In forum Organizational Development in Device Companies

8 years ago
RE: Collaboration projects

I think matrix organization structure is most ideal for collaboration projects. To break down what a matrix is, it is an organizational structure that distributes responsibilities among two or more di...

In forum Organizational Development in Device Companies

8 years ago
Risk Management Mistakes

I came across an article online that highlights 4 reasons why a company's risk management approach may be wrong. It was an interesting read and indicates the following as major errors: 1. Risk managem...

In forum Risk Analysis for Medical Devices

8 years ago
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