In my company, there are 2 main categories for our testing deviations: deviating from a standard, or deviating from the protocol. For testing our implants we follow ASTM standards for our testing proc...

I think the best strategy is to get the disagreeing parties together in a room and have a face to face meeting so that everyone can understand the full picture and determine a strategy for moving forw...

A good way to prevent scope creep is to gather inputs from the customer early on in the project and lock down the scope as early as possible. I agree with cdj24 that in some cases scope creep can be u...

In the lecture for this topic Dr. Simon explained the difference between process validation and process verification. Process validation is definitely the preferred method, as it ensures the process i...

I'm interested to know if anyone with experience in industry has experience with performing validations on measurement systems, such as Gauge R&Rs (Gauge Repeatability and Reproducibility). Simila...

In my company, the first step in performing a change is to submit a change request via our Windchill software. This request goes to the change administrator who either approves or reworks the change r...

I agree with the posts above that state that it is important that medical device companies have both a proactive and reactive risk management system in place. Although I agree that being proactive and...

I agree with the 6 steps outlined by moniquet07. I would just like to elaborate on the importance of the PM developing the the task scheduling with input and feedback from the resources who will be ex...

I have experienced this situation several times in projects, and I believe that often it is due to a lack of understanding of these seemingly simple parts of the project that may take much more time t...

Similar to Viraj D, I'm familiar with FDA regulations from my experience in industry, but I really didn't understand EU regulations until I took this class, so I found it very interesting to learn abo...

In my company our process validations include machining validations, welding validations, validation of assembly fixtures, and finishing validations, such as electropolish validations. One of the vali...

Although proper use of project management tools can definitely mitigate the risk of pitfalls, as wms7 mentioned, even in relatively simple projects, the unexpected will almost always happen. However, ...

From my experience with working on projects in industry, I would agree with the above posts that often during a project, it is necessary to go back to the planning phase to re-evaluate the project bas...

I did my undergraduate degree at NJIT in ME, and I thought that I got a decent amount of exposure to technical writing, especially in the form of lab reports. Although it may not be the same as design...

I agree with the posts above that the inputs for the DID should be gotten directly from the end user or customer. In my company the marketing department is responsible for gathering VOC (voice of cust...