I have never been in the medical device industry, but I think that the company contracts with experts as consultants for some period of time in the whole project because the company may unable to offer the experts like (physician…   Read more»

For court claims reason, it’s clear that the documentation is the main difference among the verbal and written agreements. During my previous job, which was service advisor at one of Ford Motor agency, I had to accept verbal agreements from…   Read more»

There is no doubt that all project’s members concentrate on the same goals regardless of forming way. For me, the knowledge is first criteria that we should care about it. Also, if I were a project manager, I prefer to…   Read more»

I worked at a company that follows the matrix organization in its projects. I can tell now it was a weak matrix organization according to definitions that we saw on the lecture. I thought it was good type of organization,…   Read more»

For my project, the team members had kick off meeting through Google Meet, which we got know each other and the project manager shared the project’s tasks. For my role, I’m the marketing guy that means I started collecting input…   Read more»

Generally speaking, I think since the transference way is not available as risk management tool for medical device, the acceptance should not be considered in medical device unless avoidance and mitigation options are impossible to be selected. However, some cases…   Read more»

I think all posted comments have mentioned that with high severity risks the avoidance is the right choice, and I totally agree with that. Therefore, the level of severity gives us a clue to which choice we can consider. I…   Read more»

My opinion based on my experience at Duyar Vana company in Istanbul, Turkey, I worked at the manufacturing department. The company uses both Failure Mode Effects Analysis (FMEA) and Fish Bone Diagram to do risk analysis. As an engineer at…   Read more»

Design Verification and Design Validation are phases of Design Controls, which used to test the design and ensure that the medical device inputs are match the outputs and the user need. Some cases adequate with verification process and do not…   Read more»

A successful validation process for a medical device requires the medical device is typically matching the user needs. In validation, there are some obstacles that may face this process. These obstacles need to be avoided. First, communication lag may put…   Read more»

In medical devices, validation is generally important to make ensure that the intended usages of a device are safe, if there is an update or change has been added to the device, and a clinical trial is required. So, I…   Read more»