Hi Viraj, it really depends on the equipment or the process you are trying to validate. There are some, for instance if you purchase equipment from a vendor, there are cases were you can validate this equipment as an COTS…   Read more»

Interesting topic, but is the balloon popping an isolated incident or does it happen all the time? I do agree that more time will be needed by R&D to address this issue, but is this product already in the market?…   Read more»

For my senior design project, we were working on a non-invasive vascular stiffness monitor, we were prototyping on bread board, which connected to a an ossciliscope for data analysis. Half way through our project we realized that the breadboard had…   Read more»

I have had a a few experiences in which completion of projects have been delayed, I was validated a new piece of lab equipment, during the validation process i ran into delays ranging from the acquisition of testing equipment to…   Read more»

I would say that it depends on the severity of the change, if its a major change that all documents should be adjusted and perhaps another safety assessment may be needed if it changes the function of the device. If…   Read more»

The essential differences are is that DMR contains all documentation for the design and manufacturing of the current product and all process are fully documented, while DHR contains all production/process records of the device.

Chris

From my experience the tracking of medical devices in the post market surveliance often comes consumer feedback itself, we have a team that dedicates themselves to addressing potential issues. The address concerns with the use of the device and often…   Read more»

I had that happen to me when I was working in the consumer sector, I was reforming out of a ester that is now discontinued, it was believed that it was going to be a very simple reform of a…   Read more»

Based on the information give, since the material has been in the development phase for a decade, the potential of the material should by now be known or at least have a pretty good idea on what it could do…   Read more»

Hi All, I can definitely agree that a budget cut will effect the project, thus area that may have been clear may have to be reanalyze to take into consideration the budget limitation. This aspect is very important for the…   Read more»

In my opinion an SOP, should be created to ensure repeatability of a process/ procedure. That being said it should be implemented when they are finalizing the product. Such an example would be if we create a new surgical stapler,we…   Read more»

Hi All, Engineering change orders are an interesting and important topic. I am currently working on a few change orders for the CAPA that I am working on. I am basically updating test methods for laboratory testing equipment , which…   Read more»

I completely agree with the comments above, the fitbit is not a medical device and it should not be liable to provide ” accurate measurements” if you think about the concept of properly monitoring heart beats, the fitbit is a…   Read more»

There already is a ” right to try” legislation with regards to having experimental drugs given upon the request of a terminally ill patient. I attached two articles below that explains…[Read more]

Great topic, as a the comment above me mentioned the FDA acts as a ” Gate keeper”/ filter for consumers and ensures that good quality products reach the market that have a minimal amount of impact on their well being….   Read more»

As Fady mentioned, essentially they have the same content, but the major difference is that the technical file has the current standards/specifications for the device and it does not take into consideration the design history. In my opinion, the DHF…   Read more»

In my opinion I would consider the DHF to be a living document. Often times in a products life span there could be changes in materials/processes and its good to look back at historical data in order to compare data…   Read more»

By definition, verification evaulates whether or not product or system complies with a requirement, specification, or regulation, while validation assures that the product meets the needs of the customer or in other words meets the operational needs of the user….   Read more»

I definitely agree with the posts above, the design control in particular that should be reevaluated should be the verification/validation aspect of this product. Risk analysis should be conducted as well. It is important to take into consideration is that…   Read more»

I agree with the comments above validation and verification should be approached at the close stage of the project. The idea is that you want to ensure that it meets the user needs through validation and you look at the…   Read more»