I do agree with the above posts up to a certain extent. Yes the testing portion of any trial can be very time consuming and daunting but accomplishing your goals is the most rewarding. Ideally in a R&D facility, engineers…   Read more»

I agree with the comments above. These simulations helped me understand how engineers have to solve issues on a daily basis. From simulation 1 to simulation 3, I had the opportunity of putting in practice every lecture learned throughout the…   Read more»

I think the combination of the course options we have is sufficient since we get a taste of statistical analysis, CAD design, Coding (Labview/Matlab), & medical device development. With this being said, we get a opportunity to take two classes…   Read more»

I do think that maintaining the budget of a clinical study could lead organizations to conduct the studies in developing countries to save on costs. Balancing funding with results might not be easy since it could be difficult to plan…   Read more»

I have not had any experience yet on clinical studies but I would like to develop a little more on blinded clinical studies. In this type of study, subjects are blind to which treatment is given. There are three types…   Read more»

Corrective and preventive action (CAPA) can be viewed differently by employees within pharmaceuticals and medical device companies. Some see CAPAs as simply an onerous task given to them to complete in order to “stay compliant,” while others look at CAPAs…   Read more»

Recently at work, we faced that most real time products coming out of the chamber were dictated as non-conforming upon pressure decay testing. At first, R&D engineers thought that probably the technician was not performing the test as specified in…   Read more»

GMP’s ambiguity does make it more difficult for startup companies. These companies could have the required description in order to have a compliant quality system but they do not have an pre-existing framework that they could follow. Therefore, creating quality…   Read more»

No GMP will certainly result in a cheaper process and the product will also sell at a lower price. Nevertheless, GMPs is what establish your credibility to other organizations, to your customers. It proves that you are a viable supplier…   Read more»

Product failure can be described in two categories; product risk & business risk. Product failure is not a fun thing to deal with and a lot of companies deal with it in different ways. Some companies have a non-conformance tracking…   Read more»

Interpersonal skills and business skills vary from one company to another specially in medical device fields where it’s not so easy to do everything yourself with all the ISO & FDA regulations. I’ve seen and heard about companies that take…   Read more»

In my opinion, there is really no scrap of a project due to patent issues or money. There is always a priority change in which project management plays a huge role depending on the business needs. I’ve seen some products…   Read more»

During post-launch product management, it is very important to keep track of the product’s quality performance by interacting with the customers and keep track of it. This way you are ensuring that customers are not only satisfied with the new…   Read more»

Hi gh56, I do not experience on this area yet. Nevertheless, I believe that it is difficult to pinpoint any role as the most important role for a product manager since they are equally important and they all relate to…   Read more»

If the machine severely failed in manufacturing, the first step is to investigate the root cause of the failure. Once the root cause has been found, a correction must be performed. If the failure can have a product risk then…   Read more»

Hi all, After my undergraduate, I have to say that I really did not have any background knowledge of how the industry worked in regards to medical devices. I learned a lot from part 1 and part 2 MDD. From…   Read more»

Hi all, Even though I still do not have experience in Validation, but I think that a type of Validation could also be Revalidation. Revalidation means repeating the original validation effort or any part of it, and includes investigative review…   Read more»

HI gh56, I think that under the FDA the QSR embraces the same “umbrella” approach to the CGMP regulation that was the underpinning of the original CGMP regulation. Because the regulation must apply to so many different types of devices,…   Read more»

For the Vascular Graft Weaving Line – weaving the polyethylene fabric tubes that make up a vascular graft… I believe that the IQ, OQ and PQ will be as following: IQ- The machine weaving the polyethylene fabric has been installed…   Read more»

Hi all, A DHR is a key deliverable from design controls and it is a checklist that is used during manufacturing of the device. The DHR, is created during design controls but it is not used until manufacturing of the…   Read more»