Sheila Sarathy

Forum Replies Created

RE: Upper vs Middle Management.

I also believe I can excel in both areas; Upper management and middle management. I might prefer being in a position of upper management because I find myself to be quite strategic and pretty good at ...

In forum Organizational Development in Device Companies

4 years ago
RE: Forming a Project Team

@cassiem I totally agree with you on the fact that the team would be most effective when made up with different types of people. When you involve different types of people on the team with different p...

In forum Organizational Development in Device Companies

4 years ago
RE: Forming a Project Team

@cassiem I totally agree with you on the fact that the team would be most effective when made up with different types of people. When you involve different types of people on the team with different p...

In forum Organizational Development in Device Companies

4 years ago
RE: Forming a Project Team

I feel like its better to work with people who are more knowledgeable in their department role. Working on a project team with people who already have a pre-existing relationship with can get dicey. T...

In forum Organizational Development in Device Companies

4 years ago
RE: how far is "As Far As Possible"

Apparently it changed from "as low as reasonably practicable" to "as far as possible" Basically the first one, ALARP; allows a manufacturer to include economic impacts into considerations as to what a...

In forum Risk Analysis for Medical Devices

4 years ago
RE: To risk manage or not to risk manage?

Patients usually don't even realize that they accept the risks that are associated with the medical device. Although the risk management process can be tedious, it is very essential for making sure a ...

In forum Risk Analysis for Medical Devices

4 years ago
RE: Dealing with risk

An example of a risk that can be instance where it would it be okay to accept the risk in medical device development is a risk that there wont be enough of the device to sell on the market because it ...

In forum Risk Analysis for Medical Devices

4 years ago
RE: Dealing with risk

An example of a risk that can be instance where it would it be okay to accept the risk in medical device development is a risk that there wont be enough of the device to sell on the market because it ...

In forum Risk Analysis for Medical Devices

4 years ago
RE: Designing Verification Tests

@anthonynjit This is true. Developing protocols based on tensile strength of a device after repeated use is a commonly overlooked factor. I would have to believe its because big corporations might sig...

In forum Introduction to Design Controls

4 years ago
RE: Validation vs Verification

@cem34 I'd have to disagree with you. I believe that validation is incredibly necessary for a medical device. I could say that I work in the industry because I work with instruments that are use to sc...

In forum Introduction to Design Controls

4 years ago
RE: Customer Needs and Design Input

@mattie718 I would have to agree with you in the sense that the Design Input Document (DID) and Design Specification Document (DSD) are similar documents. But I do think that the DID is most vital bec...

In forum Introduction to Design Controls

4 years ago
RE: Design Controls: What do you deem most important?

With Design Control, I believe that Output is the most important part. The output is considered as any work that's produced at the end of the design. That would include any drawings, manufacturing ins...

In forum Introduction to Design Controls

4 years ago
RE: Design Verification Ethics

I believe that would depend on if the company is working on something with high demand and urgency. For instance, I work for a laboratory that has a pcr lab that processes covid19 samples. With the he...

In forum Introduction to Design Controls

4 years ago
RE: Placebo-controlled trials: Are they ethical? Are they necessary ?

Placebo controlled trials are ethical from a bigger picture sense. There is a greater good at hand when conducting them. It is for a good and moral purpose, so therefore, it should not be considered u...

In forum Clinical Research Basics

4 years ago
RE: WHAT IS THE OBJECTIVE OF CLINICAL TESTING ON PHARMACEUTICA DRUGS?

I believe that the majority of the reason for why clinical testing/trials are done for pharmaceutical drugs is to document any potential or inherent side effects that may transpire when taking the dru...

In forum Clinical Research Basics

4 years ago
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