The purpose of the design validation is to confirm that the product’s intended use is what it’s designed to be. Not just the product, but whatever the project is. For example, during my internship there was a project that needed validation of the packaging. The purpose was to make sure that the packaging process did not introduce for example…[Read more]

I think the most important part is determining what the root cause of the failure is or else every solution you come up with will just be a bandage solution. Temporary solutions won’t fix the problem long term and might cause further trouble down the road. Determining the cause can involve further experimentation to confirm the problem. Once this…[Read more]

I believe that the system is okay as is. I believe the ability to approve medical devices based on predicate devices speeds up the process of approving necessary devices for the population. This is a bit of a different example but for rare diseases know as orphan diseases, which only affects a small percentage of the population the FDA offers the…[Read more]

I believe that all products go through a decline cycle. I’m thinking how technology seems to evolve in terms of phones. Phones themselves are always in high demand and the use of phones has actually increased over the years. However phones are constantly updated and new generations are introduced to the market. This is how they stay relevant.…[Read more]

I believe that verification of the product comes first and is followed by validation. Verification I would think happens towards the middle or after the midpoint of the project development and is followed by validation. A semi-final design is needed and has to be made in order for verification of that design and validation of that design to…[Read more]

Functional organizations initially sound like the better organization because hierarchy is clear cut and you can foresee where you have the opportunity for growth within the company. This could provide reassurance for employees. However, the lack of interdepartmental coordination and full control of decision making on a topic being assigned to one…[Read more]

Business and market research play an important role when initiating a project idea because you want to make sure you are meeting the needs of your market as well as you want to know there is a market for the product in mind. Without demand it would be difficult to sell the product being created and it wouldn’t be profitable. In the company I…[Read more]

It is not in the best interest of any company to try to deceive or commit fraud in classifying their device as it taints all future submissions to the FDA if they are even allowed to continue operating. Additionally it raises many ethical concerns regarding their decision making and in my opinion safety concerns of all their other products already…[Read more]

Hi Everyone, My thoughts are that a risk assessment and market discovery would have to be done. Is there a large demand for this new device and do the pros outweigh the cons risk wise? Would it be making a significant impact on the health of the population? Are there other projects in the company that would make a more significant impact on…[Read more]

Though it is important for a project manager to be multi-skilled, have strong communication skills, technical knowledge, and risk management skills. These can all be encompassed by the single skill of being proactive. A proactive management will utilize all his skills to manage his teams. A successful project manager is more proactive rather than…[Read more]

Hi Everyone,

Growing up it was always emphasized the importance of doing well in school and personally not much was said on developing interpersonal skills. So i’m inclined to initially say that technical skills deserve a higher percentage in how successful you can be. However, it’s your interpersonal skills, the contacts you create and how well…[Read more]

Hi Everyone,

I currently work as a temp/part time quality engineering intern at MTF Biologics which is the biggest tissue bank in the world. I’m not too familiar with the terms Matrix or project based organization but I would say that MTF is a matrix based organization. There are different departments such as quality engineering (QE) and…[Read more]