I personally think the matrix organization is most effective for running projects. It may seem a bit complicated at first, especially for someone who is currently working in a functional or project ba...

I am unable to post the link to the article I referenced, but the website is MDDI (Medical Device and Diagnostic Industry), article title is Medical Device Quality Planning.

The quality plan is a very essential document, because it outlines the procedures/methods you intend to follow in the project to ensure that the product you develop meets all quality standards of your...

I work within a matrix organization, but as Dr. Simon mentioned in his lecture about his experience with a previous company, I would label it as a weak matrix organization. The reason I would call it ...

I do not have any experience with clinical trials, but I think you raise a very important issue. Does over-regulation lead to a decrease in innovation? I believe that it definitely does, and there is ...

In addition to the points mentioned above, from my experience a very critical step in the project initiation phase is to lock down the scope of the project. In my company I believe that one of our big...

I would like to add to the discussion by talking about my experience with 510k submissions. It definitely is possible for companies to embellish characteristics of an implant or testing results to cla...

I do not personally have experience with getting combination devices approved in the EU, but I did some research on this topic and I found an interesting article explaining that the EMA is considering...

One of the similarities between the technical file and a 510k submission is that both of these submissions must be reviewed and approved by the appropriate authorities before the company can market th...

I cannot post the link to the article where I found this information because I keep getting an error. However, the website was called Emergo Group.

Orthopedic devices such as hip and knee implants are classified in both the US and EU. In the US these devices are considered class II, but I did a little research about how these devices are classifi...

I tried to post the link to the article but I kept getting an error. Below is the title of the article for your reference. Title: COMBINATION PRODUCTS - 6 Guidelines to Follow When Developing Combinat...

I do not have experience working with combination devices, but several of the posts above mentioned the option of submitting an RFD, so I did some research on this topic to see if it is as easy as it ...

I work in the orthopedics industry, specifically in the spine industry. Most of the devices that my company develops are used in spinal fusion surgeries. By far the biggest trend in spinal implants is...

My company uses Microsoft Project to manage project timelines, and we use Windchill to manage project documentation and our DHFs. I would say our project management awareness is medium. I feel like we...