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Sheila Sarathy
@sheila-sarathy
Eminent Member
Joined: Sep 3, 2021
Last seen: Nov 20, 2021
Topics: 0 / Replies: 40
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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 fin...

3 years ago
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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 diff...

3 years ago
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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 diff...

3 years ago
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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...

3 years ago
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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...

3 years ago
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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 b...

3 years ago
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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 enou...

3 years ago
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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 enou...

3 years ago
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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...

3 years ago
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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 ...

3 years ago
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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 docume...

3 years ago
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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. ...

3 years ago
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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 p...

3 years ago
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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 pu...

3 years ago
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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 s...

3 years ago
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