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AniketB
@aniketb
Trusted Member
Joined: Jan 26, 2019
Last seen: Nov 26, 2019
Topics: 0 / Replies: 78
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RE: NDA vs Patents

A patent is when we do/think of something unique and has not been done yet, only then we are eligible to apply for a patent. While an NDA is something...

5 years ago
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RE: Restrictions for physician's gifts

I think the gift restriction is a good thing as not all companies are at the same level in terms of their budget, one company has the best product but...

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

A written agreement is the one done on paper and signed by the people agreeing on the contract/ terms within the document. A verbal agreement is when ...

5 years ago
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RE: Medical Device Project

So, we had decided to meet on video call as its difficult to manage to come for an in-person meet every week, we have completed the DDP, DID and have ...

5 years ago
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RE: Forming a Project Team

While forming a team I don't think getting a person who you know on a team will benefit unless the person is good at the job that he/she has to perfor...

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

I would prefer working in a matrix organization as there is direct communication within the team and there are no silos nor is there any competition w...

5 years ago
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RE: Manage Risk

For a low severity risk, we can accept the risk depending on its occurrence or try to mitigate the risk.While or the high severity of the risk should ...

5 years ago
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RE: Risk management and Labels

The first option is to design it out, which is ideal as the product is not in the market yet and if there are any design changes that can be done to r...

5 years ago
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RE: Risk Management Tools

FMEA is ideally used for risk management as it gives an idea as to where and how the product might fail and what impact each of the failures will caus...

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

FDA will first see that the product does not provide any risks to the person, also make sure that the standards set by the FDA are followed by the man...

5 years ago
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RE: What are Design Controls?

Design controls are FDA guidelines that are required for making a device. Design control has a set of files under them such as the DID, DSD, DHF, etc ...

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

Gantt Chart gives an idea of all the tasks that are needed to complete and project or a part of a project within a particular time frame considering t...

5 years ago
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RE: Consequences Of Insufficient Design Controls

Design control is important as it sets the workflow of the product in the market if is insufficient Design Control then there will be no direction as ...

5 years ago
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RE: Design input sources

Design inputs are basically determined by the management, market research, users, Sales representative, and the research Scientist if he can make the ...

5 years ago
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RE: Minutes for meetings

Meeting minutes are written documentation for the attendees and the non-attendees to know what happened in the meeting and highlight all the important...

5 years ago
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