This course has been very helpful in looking at some of the other areas of the medical device industry that I have not been exposed to. Not only that, but the interaction between other students with lab experience or work experience has helped in giving me different perspectives on certain issues.

Currently, I work for a company that employs the functional organization structure. This helps in allowing all the smaller specialized groups to focus on our certain tasks at any specific point of a project. For instance, in R&D I’m solely engrossed in working and developing any direct engineering work for said project. What I mean by this is, I h…[Read more]

Hi,
Looking at these different types, the last one in particular stands out to me for certain reasons. First, the fact that the directorate have an influential vision that is applied across the company and its different branches. This circular organization also allows for sharing of workload and responsibility between different divisions of the…[Read more]

I have to agree with your suggestion of subscribing to a database rather than buying documents one off. This creates a much more sustainable business model for these organizations by ensuring that subscribers will always have access to these articles and the subscriber will continue to pay an annual fee. In theory this should fund future work on…[Read more]

Fortunately I have had the opportunity to sit in on risk analysis session for a new product. The amount of time and effort that goes into creating the EURA’s (End User Risk Analysis) is very great. There are many different functions to look at when it comes to creating your EURA’s such as Process, Design, and Application. Like you mentioned bef…[Read more]

An interesting standpoint on design control is that they protect against product liability of design defect. Design defect is concerned with claiming the safety of the product is in doubt and that the route taken to design said product, neglected to account for product safety or make a safer design. With the use of design control, specifically…[Read more]

I think its difficult to pinpoint a single portion of a DDP to be as the most crucial as all portions are critical to a project’s success. To answer your question, a gantt chart is a very important in terms of outlining the tasks related to the project, the responsible party for each portion as well as the expected timeline to completion. The…[Read more]

Yes, while a DHF is not needed for an EU release product, design controls are still an integral part of the process and are still integral. While that may be the case, I believe any company looking to expand its platform to an international level, can always beneifit from “over documentation” and having a DHF on hand and constantly updated. This…[Read more]