Requirements for Design Controls 1. Design planning 2. Design input and output 3. Design verification and validation 4. Design review 5. Design changes 6. Design transfer 7. Design history file Design...

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. Operational Control. Staffing Flexibility. Continui...

Verification is the most important part in any project especially even in medical devices where there is interaction between devices and humans. Verification would make sure that device works in accor...

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 get to know all about the product development. It n...

Your goals when defining Design Inputs include: Capturing all functional, performance, safety, and regulatory requirements. Build upon User Needs and intended use. Make sure Design Inputs are clear an...

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 as a plan to go for especially for legacy product...

I cant really think Why is it needed to use double blind study since I think single blind i.e. only patient blind must work.In double blind both Investigator and patient will not know about the drug a...

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 has proven itself in clinical trial show how safe t...

I think placebo controlled trial are very important because this would help subject have control Vs experimental subject which would help better understand the trials which would help develop the trea...

Especially in medical device companies when product are in developing stages how can a company like verb or ethicon which are working on new technology or are about to launch a new surgical robot how ...

Strengths Being the world’s leading online retailer, Amazon derives its strengths strategic advancement it has achieved on cost leadership, differentiation, and focus. This strategy has resulted in t...

Verb Surgical Vision: Translating technology and information through actions that matter. Mission: To empower surgeons with state of art robotics where everything is connected in way where everything ...

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 your partner for your small business but when it com...

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 is allowed and get one of the son onboard and lat...

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 finances and I believe that C-type provides the best wa...