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sb2363
@sybleb
Trusted Member
Joined: Jan 27, 2019
Last seen: Nov 27, 2019
Topics: 0 / Replies: 78
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RE: Factors to consider when executing the NDA

An NDA protects non-public information. The factors to consider while executing a Non-Disclosure Agreement may vary from a project-to-project. The mai...

5 years ago
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RE: Restrictions for physician's gifts

In my opinion it is fair enough and not too restrictive because the law is enforced only after there have been cases where the physician was easily br...

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

A written contract obviously has an advantage over a verbal contract. The terms Verbal and Oral contract can be used interchangeably and mean the same...

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

I believe I would like to work in a matrix based organization as it gets the team members and managers to work on a specific goal. There is quick flow...

5 years ago
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RE: Medical Device Project

We had our first in-person meeting the very next week Friday our project team was formed. We have decided to meed every Friday evening to check our pr...

5 years ago
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RE: Forming a Project Team

When given a choice to be able to choose a project team, which mostly happens in a matrix organization the project manager would like to choose a subj...

5 years ago
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RE: Manage Risk

I would choose acceptance for low severity of risk as this is a good strategy to use for very small risks that won’t have much of an impact on your pr...

5 years ago
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RE: Dealing with risk

In the medical device industry risks are identified by the residual safety risk zone for each risk identified to determine it's acceptability. They ma...

5 years ago
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RE: How to run a risk management meeting ?

In my opinion risk management meetings are successful when there is a full participation from all the members of the team. Brainstorming becomes easie...

5 years ago
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RE: Consequences Of Insufficient Design Controls

Deign Control problems seem obvious only after adverse events, before that they are not so evident. Not starting out with a set of product requirement...

5 years ago
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RE: Factors to Consider While making Gantt Chart

In my opinion it will be beneficial if a particular pattern is followed while making a Gantt chart. Having the dates displayed right at the top for in...

5 years ago
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RE: Design Verification & Validation

Verification and Validation are two different processes where validation follows verification. Verification is where you test/verify that the design o...

5 years ago
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RE: What are Design Controls?

Design Controls are a part of 21 CFR part 820.30 which are presently adopted into the ISO 13485:2016 standard to ensure that the device or the even a ...

5 years ago
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RE: Design input sources

I guess the sources of design input will depend on a number factors such as the customer requirements who can be doctors or patients, safety, similar ...

5 years ago
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RE: Minutes for meetings

Minutes of a meeting are essential. They contain the important points discussed in the meeting. It contains the necessary action items and the assigne...

5 years ago
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