I personally think the matrix organization is most effective for running projects. It may seem a bit complicated at first, especially for someone who ...

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 D...

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 produ...

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 wea...

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...

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 pr...

I would like to add to the discussion by talking about my experience with 510k submissions. It definitely is possible for companies to embellish chara...

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 interest...

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 approp...

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 li...

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 PRODUCT...

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 res...

I work in the orthopedics industry, specifically in the spine industry. Most of the devices that my company develops are used in spinal fusion surgeri...

My company uses Microsoft Project to manage project timelines, and we use Windchill to manage project documentation and our DHFs. I would say our pro...