There are typically pre-existing standards for the verification testing. International ISO standards exist to insure that proper function and safety are accomplished. Additionally, for medical devices, FDA regulations define verification and validation in design control training. Proper traceability and documentation…   Read more»

I am also currently doing my senior design project as well. It is clear to see that it simulates the design control process. I would like to add that we have a design review coming up to go over the…   Read more»

That is true Roberto. It definitely depends on the product, but I agree that they will all go through the life-cycle. This however can extend over various durations as the product may be difficult to replace or not as susceptible…   Read more»

You bring up an important point krp76. Both the instructions and training play a pivotal role in ensuring that Human Factor aspect is well considered. Taking into consideration all aspects at play is important in addressing any issues of miscommunication….   Read more»

From the information I found a significant risk device is one that can present a possibility to affect the health, safety or well-being of an individual. These are often class II or III devices such as sutures, pacemakers and various…   Read more»

Hello, There are great points made above. I agree with the aspect of their similarity in terms of being responsible for the completion of projects in a timely manner. Organizing individuals, delegating responsibilities and coordinating schedules. However, as mentioned by…   Read more»

You bring up a great point Roberto. I would like to add that though many of those in the project management role are good communicators, there is an additional skill that only some have. This skill is being able to…   Read more»

I believe a majority of project management skills are applicable across the multiple disciplinary fields. These include effective communication, leadership, team management and organizational skills. These skills can be effective regardless of the industry. However, to be an effective project…   Read more»

From my time at Maquet I got the opportunity to work on multiple projects. Though departments were typically split functionally, a majority of the time an individual was assigned to each project. However, based on time constraints and the work…   Read more»

You make a great point Juan. Anything valuable in terms of an agreement should be appropriately recorded. Especially in business when valuable ideas, ventures and careers are at stake. Though, as a few of our classmates mentioned, an oral agreement…   Read more»

I would like to suggest “Medical Device Industry Preparedness” or something similar in terms of preparation for work across a variety of disciplines in the Medical Device or even a more broad Medical and Pharmaceutical Industry. I believe that this…   Read more»

Hello, I feel our class mates described the difference very well. I would just like to add that at times the idea may not be developed enough to allow for a patent application. In these cases it is advised to…   Read more»

Hi Saad, I agree with your point. However, I think it is more than just the size of the company that decides the best organizational structure. I believe it could vary based on the type of company, individuals involved and…   Read more»

I work in a similar environment. I certainly agree that the convenience of have an entire, or a majority, of the department be familiar with the ongoing projects means that if an individual is unavailable you can seek help from…   Read more»

Luisa, You make a great point. In addition I would like to point out that in a matrix organization each staff member has at least 2 bosses, as mentioned in Dr. Simon’s lecture. I believe this can add to the…   Read more»

Hello, The term ‘As Far As Possible’ certainly could pose a difficult situation. However, I believe that there should be no possible risk left unconsidered, even if it is extremely unlikely. The intentions of a medical device is to be…   Read more»

Hello, Though I agree with your thought that a Gantt Chart is important, there is much more that goes into the scheduling process. It is extremely important to keep up with this schedule as it should be a living one…   Read more»

Hello, I believe there are many aspects that are required for design input. The first is user needs, or what the consumer is looking for in the product. These needs can then be used to devise design concepts and weigh…   Read more»

Hey Saad, You bring up a great point! Inefficiency and wasting time is extremely costly to the device development process. Issues such as unclear requirements may lead to an insufficient design control and review. When the objectives of the device…   Read more»