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 Control is in place so that all documents are in place and everything can be back traced is place of problem.
Reviews are in place to on every…[Read more]

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.
Continuity & Risk Management.
Develop Internal Staff.

Disadvantages:
Possible loss of control over a company’s business processes
Problems related to…[Read more]

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 accordance with specification laid out in DSD. It all would make sure that all your inputs and out are in check whether all are in accordance with DID and…[Read more]

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 needs to be necessary that this documents needs to be updated all the time so that anytime even during product development you can refer a DHF. Since…[Read more]

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 and objective.
State Design Inputs in a way that allow you to prove / disprove them.

You also should consider all sorts of other sources to help you…[Read more]

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 products to get approval.
So here is the flow. Correct me if wrong.

1. Get all documents available.
2. Perform Gap analysis.
3. Identify what data needed…[Read more]

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 the procedure is, Even in cases when any adverse effects or any risk are shown setps can be taken to avoid those duringfg treatment. But from what I…[Read more]

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 treatment in an effective way. Because one should always have something to compare the results. I also agree that in certain cases Placibo itself would…[Read more]

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 the company reaping the gains from this course of action and has helped its shareholders derive value from the company.
Amazon primarily derives its c…[Read more]

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 is smarter,flexible, interoperable and portable.

Verb surgical is a new company made in collaboration with verily and Ethicon. Verily is formerly…[Read more]

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 comes to making business decision I would consider tell that risk factor would be the highest since their would be time when the partners don’t agree or…[Read more]

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 later there dad can show that he sold his share to his other son and now dad can get out of the firm i.e. basically he passed his company to his son and…[Read more]

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 way to get finances and apart from getting easily loan, I can even approach other companies to invest money into my company and ask investor too to…[Read more]

Quality is an and should be considered as an integral part of the company. It doesn’t matter what is the size of the company but there should always be a set form of procedure to maintain accountability and flexibility to trace a product backwards to its whole batch in situations to back trace a product lot. This all things can only be achieved…[Read more]

R&D as well as quality comes with there own set of goal. Goal of R&d is to develop and innovate new or current technology in order to strength the position of company in the market. While quality has a goal to get the products developed by R&D to be approved and certified by as many regulatory bodies as possible in order to increase the trust of…[Read more]

I have seen very few products that are being recalled very early. I think the products that are recalled very early shows how much company are concerned regarding the safety. One I would like to discuss is ATAR Reusable and Disposable Extension Cable(s) by OSCAR.
Reason for recall was risk of the extension cables separating from the connectors…[Read more]