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rv395
@rv395
Eminent Member
Joined: Sep 4, 2020
Last seen: Nov 22, 2020
Topics: 0 / Replies: 36
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RE: Advice before signing an NDA

NDA's are legally binding documents so we should read it carefully before signing. We need to be aware of the terms in the document and clarify any va...

3 years ago
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RE: Alternatives dispute resolution

Alternative Dispute Resolution (ADR) can be effective because they are speedy than going to courtroom and also reduces the cost. Moreover the result c...

3 years ago
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RE: Consultants in the Medical Device Industry

Consultants usually have experience of working in the domain of the developed Medical device and they can provide a viewpoint which the company realis...

3 years ago
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RE: Your Organizational prference; but why?

My preference would be to work in a matrix structure because it can increase efficiency to meet the demands of the project by collaboration with vario...

3 years ago
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RE: Matrix Organization- Conflict

When I worked as a Research assistant, there was matrix structure where I reported to immediate supervisor and project manager. As long as there was p...

3 years ago
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RE: Traits of upper management versus middle management

The important trait of upper management in any industry is leadership quality. They foresee the future of company and set the vision for everyone to w...

3 years ago
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RE: What is a risk management file?

The risk register is an important document in the product life cycle and it has to be updated continuously with the following information - Prior...

3 years ago
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RE: Risk Management - Identification

Like everyone suggested in the previous posts, Information Gathering techniques are proven for Risk identification. These techniques involve sessions ...

3 years ago
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RE: Risk Management Tools

Some of the basic tools used are 1. SWIFT Analysis - Standing for “Structured What-If Technique” where the project members apply a systematic, team...

3 years ago
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RE: Combination Product Phase I clinical Studies

In combination products design controls, the clinical trials takes place as three constituents - for drug constituent part, the device constituent par...

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

Drugs trials are conducted in three phases, starting with an introduction on a small number of healthy subjects, and then in large populations and the...

3 years ago
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RE: examples of controlled device changes

Document control is very essential in device changes. It helps maintain a quality system or a device. An example of controlled device change is device...

3 years ago
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RE: Blind and randomized trials

Randomization is used to reduce the bias in assigning patients to study treatment groups and it provides unbiased assessment of the effects of differe...

3 years ago
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RE: Right to Try Law

As of January 2020, it has been reported that one patient with amyotrophic lateral sclerosis, or ALS, has received an investigational drug from BrainS...

3 years ago
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RE: Adverse events (AEs)

Although I have never experienced Adverse effect during clinical trials, I agree to the possibility of incorporating wearable technologies into the pr...

3 years ago
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