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Atharva
@atharva
Eminent Member
Joined: Sep 8, 2022
Last seen: Dec 4, 2022
Topics: 0 / Replies: 39
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RE: Discussion Topic: Course conclusion and impressions

Thanks to this program, I've gained a better understanding of the medical device sector. It covered subjects generally ignored in the technical field,...

1 year ago
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RE: What are the limitations and protections of trade secrets?

Trade secret protection does not safeguard your rights as the sole owner. The benefits of trade secret law include indefinite future protection. This ...

1 year ago
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RE: Written Agreement v/s Verbal Agreement

Contracts managed to reach through spoken communication are referred to as verbal agreements. A written contract is an agreement documented in writing...

1 year ago
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RE: Traits of upper management versus middle management

High-level managers typically have extensive experience, ideally across a wide range of functions. Top management teams are frequently industry expert...

1 year ago
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RE: Malsow's law in organization

Maslow's hierarchy of needs consists of five levels of human needs that enable a person to feel fulfilled. Physical requirements include physiological...

1 year ago
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RE: Your Organizational prference; but why?

I prefer to use a matrix-based organization. Teams in a matrix organization report to several leaders inside the business. The matrix structure promot...

1 year ago
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RE: Benefits of post-market surveillance

Using core competencies: How do your team members' strengths compare to your customers' demands? Your decision to outsource will be highly influenced ...

2 years ago
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RE: What is Risk-benefit analysis ?

A risk-benefit analysis contrasts a situation's advantages and disadvantages. The objective is to determine which is more important—the danger or the ...

2 years ago
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RE: Hazard, Hazardous, Harm

SL1 incident hazard- nuclear hazard On January 3, 1961, Idaho Falls personnel were reattaching control rods to their driving mechanisms that they ...

2 years ago
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RE: Design Documents in Academia

As far as what I saw in undergraduate, there are two types of review boards departmental review board and university review board. The departmental re...

2 years ago
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RE: What FDA Looks For In A Design Control System ?

FDA examine elements including sterility, electromagnetic compatibility, human aspects, performance characteristics, risk, and compatibility with the ...

2 years ago
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RE: Design Verification Ethics

At all costs, the medical gadget should ensure verification. Before being made available, every product must pass verification. Verifying the design h...

2 years ago
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RE: Design Verification vs. Validation

Design validation is to prove the device's intended use, and design verification is to design inputs and outputs match. According to the FDA, Design v...

2 years ago
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RE: Design Verification & Validation vs Clinical & Pre-Clinical Trials

None of class 1 and even many class2 devices are exempted from clinical or preclinical studies, although they require design controls and other specif...

2 years ago
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RE: Medical Device Clinical Trials vs Drug Trials

Medical devices do not have a placebo; unlike in drug trials, a specific group receives a placebo. Drug trials can be conducted in a single-blind, dou...

2 years ago
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