I have been working as an engineer for 3 years and enjoy what I am doing. I still am not sure if I want to take a technical or managerial career path. I think I would like to gain some…   Read more»

I think there is another very important aspect to this topic that I would like to bring up. I think it is important that managers recognize what type of work motivates their employees, and give them more opportunities to do…   Read more»

The division of the company that I work for only submits 510k applications, and the FDA cost associated with submitting a 510k is $10,566. In 2016, the average time to get 510k clearance was 177 days. Just recently, my company…   Read more»

Several of the posts above mentioned how that retention is important because new hires need time to get trained in their job, and I want to emphasize that this can have a huge impact on a project. New employees will…   Read more»

I agree with everyone above that I found these classes very beneficial to me, and especially the topics covered in AMDD helped me gain a better understanding of process validation. The simulations were very realistic, and overall, both MDD and…   Read more»

My company recently underwent a restructuring and recently formed a new clinical department. Before this we really did not focus our efforts on clinical studies, as we were releasing products via 510ks that were similar to other products in the…   Read more»

Comparing the simulations with my experience in industry, I can say that they are very representative of what happens in industry. Often after submitting a proposed solution Dr. Simon would come back with something that we hadn’t thought about, and…   Read more»

I think there should be different levels of rewarding motivation, so team motivation should be rewarded separately from individual motivation. For example, teamwork is encouraged, but it makes sense that each individual would get rewarded differently because each person contributed…   Read more»

In my career thus far I have definitely found that challenging and interesting work created the most motivation for me, similar to the results of the poll that Dr. Simon showed in his lecture. When I first started my job,…   Read more»

A CAPA really just provides a systematic way for companies to address nonconformances, fix them, and prevent them from happening again. One benefit of using a CAPA to do this rather than just doing it in a haphazard manner is…   Read more»

Based on my experience in industry, internal audits are conducted on a regular basis (usually once a year) by someone who works for the company. This is just a requirement that most companies have in their procedures and makes sure…   Read more»

I think kak33 gave a very good explanation of an effective way to bring up this topic with management. An employee needs to take the initiative to write out exactly why they think that additional headcount is needed. Like kak33…   Read more»

I think one of the pitfalls of the WBS could be not breaking it down far enough. We learned that it is important to break down each task into subtasks and so on so that when you are completed, you…   Read more»

I think krp67 brings up a very interesting and important topic in regards to communication techniques and style for medical device projects, and I think many projects struggle simply because of poor communication. I think the 2 major forms of…   Read more»

I think that a good strategy could be to select a different coating from the same supplier as a short term solution to reduce sourcing risk while keeping the project on track and not causing any delays to the project…   Read more»

At my company, we recently updated our design control procedures, and in the updated procedure there was a clause that said that this procedure update applied to newly chartered projects or projects where the team decided to migrate to the…   Read more»

As tn58 mentioned that there are three types of nonconformances: minor, major, and critical, I would also say that another huge factor that determines the type of nonconformance is when the nonconformance was found. If it was caught prior to…   Read more»

I agree that small companies would most likely hire an outside contractor to perform an audit if they do not have the resources to do their own internal audit. However, sometimes even larger companies hire independent contractors to perform audits,…   Read more»

Similar to aij5, I have had quite a bit of experience working on ECO’s (my company calls them CCFs (Change Control Form)) for a product that my company acquired and it was already on the market. Unfortunately, it was a…   Read more»

I have worked on another project where it failed because of issues that it was having in the field. Our company acquired the product from another small start up company, and since the product was already 510k cleared and released…   Read more»