User’s needs is indeed an important topic to be discussed in the planning phase of a medical device project. A question that should be answered is: what questions should be considered when talking about user’s needs? I will list three…   Read more»

The stages of the Engineering Change Order are 1) Issue Identification and Scoping, 2) An engineer change request is created, 3) the engineer change request is reviewed, 4) The engineer change order is created and reviewed, 5) the change order…   Read more»

If I was a PM running a Risk Management meeting, I would, as most mentioned above, get everyone attending the meeting to be familiar with ISO 14971. I would start by getting everyone to identify the possible risks. The next…   Read more»

At my company, the engineers also must redline the change they are making to the document. This is done online using microsoft’s track change. The newly edited document is than printed as a hard copy. If the newly edited document…   Read more»

From research I did, there are 6 steps to package development for medical devices. The first step is consulting the regulations. This step is to determine if the medical device falls under the FDA requirements regulations for packaging. The second…   Read more»

From my experience working for Zimmer Biomet, I would say this company is a functional organization. I am currently working as a Quality engineer, but we work with other groups such as manufacturing and R&D. I have only been working…   Read more»

To add on to what everyone said above, the intent of the Risk Management Plan is to “Differentiate most critical product features related to safety/harm, Quantify and determine acceptability of risk, Provide focus and priority for product development and lifecycle…   Read more»

As the majority stated above, I do not think there are a lot of risk and default in the Validation & Verification procedures. The V&V procedures are “…driven by the regulatory environment and international standards.” As long as the procedures…   Read more»

This is based on the article project manager. To prepare a successful project for designing a Medical Device these steps should be taken. The first step is the background which includes history, requirements, and solution. The second step is the…   Read more»

The Quality plan is an important and essential part that should be implemented. As stated by puneet, there is a certain quality standards that must be maintained throughout the project. Also, “…deploying and executing a quality plan incorrectly can lead…   Read more»

I believe that the Regulatory Compliance will remain the same and it will be a long and tedious process for the FDA to approve these medical devices. I also believe that it will be difficult to secure funding and that…   Read more»

I completely understand where you are coming from and believe that companies should provide more resources for a team to keep up with deadlines or at least give them more time instead of canceling the project. I do think it…   Read more»

I can understand where you are coming from and do see conducting clinical trials as an expensive, long, and risky investment. The problem is that I do not see an alternative to testing these devices. One thing that can be…   Read more»

As an NJIT student in the BME department, I personally believe this is a proper investment. Ceteris paribus, what separates two engineers are their interpersonal skills. However, a key assumption is that both individuals have a solid foundation in their…   Read more»

A real industry project is actually very similar to how simulations are done. The similarity is that each member of the group usually does their own research before meeting. When you meet in person you will discuss possible solutions as…   Read more»

As someone who works in industry, interpersonal skills are very important in order to be successful. Interpersonal skills include verbal communication, listening skills, problem-solving, decision-making, and ect. These are extremely important because a successful engineer is able to listen and…   Read more»