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smitshah
@smitshah
Trusted Member
Joined: Sep 11, 2017
Topics: 19 / Replies: 56
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RE: What FDA Looks For In A Design Control System ?

Requirements for Design Controls 1. Design planning 2. Design input and output 3. Design verification and validation 4. Design review 5. Design change...

8 years ago
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RE: Design Transfer

Most of the point are covered in the discussion above but I would like to add some more points to it. Cost And Efficiency Savings. Reduced Overhead. O...

8 years ago
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RE: Why VERIFICATION is important? and Your ideas to improve Verification process ?

Verification is the most important part in any project especially even in medical devices where there is interaction between devices and humans. Verif...

8 years ago
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RE: How to ensure your DHF is audit ready ?

Design History file (DHF): Is a file that contains almost all the document from DID,DSD,DOD etc basically when you go back and look at this file you g...

8 years ago
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RE: Design input sources

Your goals when defining Design Inputs include: Capturing all functional, performance, safety, and regulatory requirements. Build upon User Needs and ...

8 years ago
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RE: Design Controls for Legacy Combination Products

As some of you mentioned to retro spectically find as many document as possible and move forward from them but here is something which I would suggest...

8 years ago
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Replies: 108
Views: 18622
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RE: Clinical Studies

I think with every new procedure being introduce or proposed it always has its adv and disadvantage, but i think in case of medicine something which h...

8 years ago
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RE: Placebo-controlled trials: Are they ethical? Are they necessary ?

I think placebo controlled trial are very important because this would help subject have control Vs experimental subject which would help better under...

8 years ago
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Replies: 24
Views: 3131
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RE: Medical Device SWOT Analysis

Strengths Being the world’s leading online retailer, Amazon derives its strengths strategic advancement it has achieved on cost leadership, different...

8 years ago
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RE: Discussion Topic: Mission and Vision statements

Verb Surgical Vision: Translating technology and information through actions that matter. Mission: To empower surgeons with state of art robotics wh...

8 years ago
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RE: Partnership characteristics

Partnership is good from business point of view only when its a small scale business or when you have enough finances available in combination with yo...

8 years ago
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RE: Family Businesses

Sole propretorship can not be sold or passed on under the law but the other way of doing this would be convert the sole propretorship into a llp which...

8 years ago
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RE: Types of Corporations

I would register my company as c-type corporation because I believe that when you start your own business the most important thing is to arrange finan...

8 years ago
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