I was also lately scrolling through the topic and first thing I found that this types of devices are not yet classified under fda but it has drafted to classify in class 1 device and is not going to lay…   Read more»

There have are many instances when the device has dual capabilities which falls in both the CDRH and CDER but first we have to determine what the primary purpose for device for example its a antibiotic releasing hip stem than…   Read more»

I really agree with everyone above that Kick-back law is one of the thing to make sure patient gets the best service for which they come for and not something that is good for them just because sales rep offer…   Read more»

I liked this class a lot for the sole reason I got to know where to work and what things are needed to get to the position I like. The other thing that really I found useful that this course…   Read more»

I haven’t experienced it but one thing this non compete agreement mention mostly is that you have to pay certain amount of money to the company if you want to break the agreement But if you really impress the other…   Read more»

I think the best strategy over here would be one in which company can utilize its resources to the fullest. So i would say from company point of view Matrix organization are very effective where it can get its employee…   Read more»

I would like to work in Project based organization. Since I would like to work as a quality or regulatory department and I see in this it is better for person who want to work in department. the only disadvantage…   Read more»

Few of the mistake that company make that I came across are 1. Not considering opportunities – just threats 2. Confusing risk causes, risk events & impacts 3. Using checklists and not ‘scanning the horizon’ for other risks 4. Understating…   Read more»

I think that it worth buying this standards from regulatory department because if they are the one who are gonna finally approve our product for sales if the device specs are not withing the device specs as they have suggested…   Read more»

Factors to be considered for benefits vs Risk analysis by analysis. Uncertainty:is an important factor, since at any point in the total product life cycle, there is never 100% certainty regarding the safety, effectiveness, or quality of a device. However,…   Read more»

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…   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…   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…   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…   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…   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….   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…   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…   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…   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…   Read more»