This is a very Interesting topic to Discuss on since its brings professional experience as well as new idea. As a PM i would first ask my team to study about the risk and complaints about other type of similar devices in the market and to make a list of it and later ask to check if our device has similar issues. After that I would ask my team to…[Read more]

I think Risk/Benefit ratio is something only used to decide at the beginning when the company has to decide whether or not to go ahead with the project. Whether the benefit is worth the risk or is Risk to high for the benefit the company will make. It is something really important for a business to survive.
Other Risk we talk about is what risk…[Read more]

If a company make any advertisement or any claim via any resources that company becomes liable to that claim in other words if company claims that’s there prosthetic limb can be used for extreme sports they have to do test and trials to successfully show that implementation. FDA regulation makes company abide to any claim they make but in terms of…[Read more]

I would prefer to choose Matrix organization with a strong matrix i.e where project manager would have more power since that would mean once the project manager have the functional staff than staff has more responsibility towards project manager than the functional head but here functional head would have the power to select the staff so that he…[Read more]

Whenever there is a change made to an existing device first thing a company should do is check whether the change affect safety, efficacy and performance of the device. This information can be documented in a Letter to file (document that used for internal record) or a PMA/510K based on device classification and regulatory logic. In the example of…[Read more]

Now a days many companies have been trying to release a multi purpose device with combination of drug and device. In this case products are classified according to nature of primary job it was originally made for but in cases when it is difficult to identify which organisation does it fall under a written request is send to FDA it is called IDE in…[Read more]

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 any strict rule on this device sincethey promote health and maintain good living standards.
Although this standards should have come way back.

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 it primary purpose is to support hip rather than drug release so it first falls in CDRH class 2 medical device than we have…[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 something in return for it. But I really think with all this in place I almost agree with everything but what disturbs me in this is the…[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 was more from Industrial point of view that let you to have insight into the workflow and it helps us in a way to get internships by already knowing the…[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 company for which you are willing to work with they have this special lawyer that goes through the non compete agreement who have…[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 worth the money it pays. But from employees point of view this would be to much pressure and work to juggle with and this would…[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 is getting into high end project but the selection of the person in the project team would be most closely based on the performance of…[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 risk impacts, and not scaling the
impacts based on project drivers
5. Not using 100% probability during plann…[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 that might lead to more scrutiny of the device approval.

Different ISO standards are charged differently when it comes to…[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, the degree of
certainty of the benefits and risks of a device is a factor FDA considers when…[Read more]