williamzembricki

Forum Replies Created

RE: Dangerous Syndromes for risk management

As a risk management chairman in my fraternity I fell very strongly that risk is a big deal no matter what you do. Obviously while working as a fraternity member you are more worried about suspensions...

In forum Project Management Process and Medical Device Development

7 years ago
RE: Inputs for Design Input Document

Engineering should be involved when designing the DID. The engineers will be able to give a more educated feasibility rating. Also, even though details are not needed as much in the DID as other aspec...

In forum Project Management Process and Medical Device Development

7 years ago
RE: Variance During M&C

When planning and executing any project it is almost normal to fall of schedule I believe. Even when developing a gantt chart there is a critical path and supplementary paths that allow time for slow ...

In forum Project Management Process and Medical Device Development

7 years ago
RE: Safety Recalls

I do believe the label is just as much a part of your product as any other aspect. If a label falls off and a product is used incorrectly a company could be liable for leaving the consumer unaware of ...

In forum Introduction to Project Management

7 years ago
RE: Unapproved Device

This is a very interesting topic that you have brought up ap962. The knowledge that as934 shared is very knew to me and is a very interesting concept to rad up on. It is good to see that there are ste...

In forum Introduction to Project Management

7 years ago
RE: Inadequate Testing

Having previously worked in the medical device industry I have seen the testing they do on products that have already been tested and approved and I can say it is very intensive. To see that products ...

In forum Introduction to Project Management

7 years ago
RE: Validation and Verification

The risks in a failure during the verification and validation is missing details that will later become a large issue for the engineer or other department that is running the project. Also, not thinki...

In forum Introduction to Project Management

7 years ago
RE: ''Quality Plan'' meaning ?

Quality will eventually be one of the largest resources a company has is its ability to be confident that the product is able to perform after distribution. The quality testing will also come under hi...

In forum Introduction to Project Management

7 years ago
RE: Your Ideas about How to prepare/write a Successful Project Proposal

I believe that biggest importance with handling a project proposal is to pay strong attention to the details when making the proposal. When details or omitted or forgotten they can become a way larger...

In forum Introduction to Project Management

7 years ago
RE: FDA Approves First Digital Pill in USA

I believe when deciding the primary mode of action, you should see what is the main function and what is the secondary function. The primary function of the digital pill is to deliver the mental illne...

In forum Introduction to Project Management

7 years ago
RE: Meat without Murder

The idea of transplanting a artificial human organ into another human is clearly a Class III procedure. This would definitely require a tremendous amount of testing and would be strictly regulated by ...

In forum Introduction to Project Management

7 years ago
RE: Fitbit Medical Device?

The new generation of smart watches does make it a slight bit confusing about whether or not they should be considered a medical device. The device does not monitor blood pressure but it does attempt ...

In forum Introduction to Project Management

7 years ago
RE: Ideal project team

The most important thing for me in a group aspect is the ability of the team to communicate and work together. A team that is less talented but able to work together well will normally surpass the tea...

In forum Introduction to Project Management

7 years ago
RE: Interpersonal skills vs technical knowledge

I believe that it is the schools responsibility to teach the technical aspects of the field. I think it is on the student to learn the outside business and social skills needed to succeed in business....

In forum Introduction to Project Management

7 years ago
RE: Discussion Topic: Share your project management experience

My project management skills are from the corporate standpoint and more from the individual projects I have taken on through my personal life. I have handed school projects well and often taken the le...

In forum Introduction to Project Management

7 years ago
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