These things happen in the industry and it’s quite common, but the only thing that matters is all of them sorting things out and working effectively to give a good quality product. As long as the person in doing what…   Read more»

Analyzing the task at hand, comparing the current task with the previous tasks that were done by the company and then taking the appropriate decision as to how much time would be required. When the PM is new this is…   Read more»

Yes I do think assigning the time frame for each task is a tough ask and I think to assign the task the appropriate time the PM has to look into the past to see if such a task was…   Read more»

It’s true that marketing team brings most of the inputs for DID as they are the one who handle all the service requests and know what is wrong with the device. Learn from the mistakes of the earlier generation device….   Read more»

I used to work in a opthalmology devices manufacturing company, the product i was working on was fundus camera. During the planning phase we were working with a doctor who used to give us inputs for each phase of the…   Read more»

i don’t think the group leader/ risk management leader will do that as investor’s invest a lot of money in the project and if the group leader/ risk management leader somehow show that it’s a low risk project and go…   Read more»

I disagree that some products don’t decline, every product has a life cycle as mentioned by Dr. Simon and hence there is a decline in the sale of the product once a good alternative comes in the picture. In this…   Read more»

I really don’t think there is any faster way to get an approval as the document needs to be studied properly before being passed ahead, which will take time so I feel one week ahead before the meeting is enough…   Read more»

I think we have to go through each aspect of the experiment we are going through, and then recheck where we are failing like in this case there was only one thing that was not justified and hence we went…   Read more»

Initiating an idea is the hardest part of Design control as you need to have the market knowledge and if there exist any device similar to the idea that we have in mind. Market research is important as without that…   Read more»

I haven’t been a part of the Industry but I want to be involved in the planning phase of the design control process as this is the crucial step for all the other processes to follow. The project should be…   Read more»

I don’t think the medical device community is moving towards globalization of regulatory procedures but in future, an optional global standard must exist. Each country has its own set of regulatory standards for device manufacturers, I agree with @mattie718 on…   Read more»

I don’t think there is a need for a separate classification for the device as the function of the device is known and such devices already exist in the market so it falls into class II classification of devices. If…   Read more»

FDA standards are there to be followed and every manufacturer has to follow the standards. The product should be tested for enough amount of times in suitable working conditions to be sure enough of its working, sustainability, the FDA standards…   Read more»

I think if there is a problem with the labels stating useful information about the product then the product should be recalled as labels help in assisting the customer about the proper handling of the product as well as if…   Read more»

All projects start off initially with an idea, then the idea if interesting is further discussed upon among group all the important members of the company and if they find it has potential, they move forward with the idea or…   Read more»

I feel for a project to be completed successfully and on time, the project management team should have proper communication and understanding among each other. It is always a case that one part of the project is dependant on the…   Read more»

I used to work as a Sales and Service engineer at intuvision labs which were an Indian company that manufactures low-cost fundas camera. I used to go on breakdown calls at the client’s clinic or hospitals whenever required. I then…   Read more»