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puneet
@puneet
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Joined: Sep 9, 2017
Topics: 0 / Replies: 80
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RE: Does Product Classification also depend on the Material of the Product used?

I think that using a different material can definitely cause a change in the product classification of a product. The overall impact of the material ...

7 years ago
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RE: Validation and Verification

I don't think there are any risks involved in performing validation and verification, rather performing validation and verification reduces the overal...

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

I think that the quality plan is important because the quality plan defines how quality can be achieved in a project. Quality plans determine a plan ...

7 years ago
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RE: FDA Regulations of Medical Device-Drug

In the case of an implant coated with antibiotics, I would guess that the FDA would designate the product as a device because its primary mode of acti...

7 years ago
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RE: Fitbit Medical Device?

I think that Fitbit and other fitness wearables don't fall under devices to be regulated by the FDA. The reason being that they aren't truly medical ...

7 years ago
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RE: 510(k) clearance vs. Postmarket Approval

I agree that it would be unethical for a company to embellish their product to try to get it classified as a type II device rather than a type III dev...

7 years ago
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RE: Interpersonal skills vs technical knowledge

I think that a balance of the two skills is needed and agree with 85:15 ratio of interpersonal skills to technical skills. I think its important for ...

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

I think that the primary mode of action of the digital Abilify pill makes it a drug, rather than a device. This digital pill is more of a pill that c...

7 years ago
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RE: Determining project priority

I think that the priority of a project plays a huge role on the resources that are devoted to the project. The priority of the project will likely de...

7 years ago
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RE: Severance and Release Agreement

When it comes to severance agreements a company would want your signature agreement on the separation, even in the case of at will contracts to limit ...

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

I believe that written contracts are favorable to verbal contracts because of how much easier it is to enforce and defend that contract. With everyth...

7 years ago
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RE: Restrictions for physician's gifts

These restrictions do seem very harsh, but I believe that they are necessary to maintain an ethical business environment. In the case of not being ab...

7 years ago
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RE: Effective way to culminate inter department silos

I think completion between teams can often be beneficial as long as that completion is healthy and friendly. The key I believe in staying away from n...

7 years ago
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RE: Discussion Topic: Your organizational type

My current position is in a functional organization where each department team has a functional manager to whom other team members report to. I think...

7 years ago
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RE: Upper vs Middle Management.

I think I would be more suited for choosing upper management, but I also think I would be able to work in middle management as well. I also agree wit...

7 years ago
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