Last seen: Nov 29, 2021
Though filling up a void position temporarily is an advantage of hiring consultants, there are many other strong benefits of having consultants. Medic...
In this week's lecture, Dr. Simon mentioned some laws which restrict physicians to receive gifts from companies. The laws are Anti-kickback Statutes ...
According to me, there are many advantages of written contracts over verbal ones. Some of the reasons are mentioned below:01. A written contract lays ...
I do have different opinions than @naglaa. For startup medical device companies I would highly recommend matrix organization over functional and proje...
We have known from Dr. Simon's lecture, upper management is strategic, while middle management is tactical. Upper management is concerned with the gro...
From the lecture we know, there can be three different types of organizations where tasks are performed in three different ways. Project teams can be ...
There are many tools that can be used to mitigate the risks. Some of them are being discussed in risk management lectures. Mainly three tools have bee...
Though risk management certainly has some advantages and benefits, there are some disadvantages too. If we think about automated risk management infor...
Since there are two types of risks involved, their difference would enable us to solve them. Cost risk, schedule changes, performance and quality risk...
I would like to talk about the verification protocol imposed by FDA on Surgical masks. Inadequate fluid resistance, Inadequate barrier for bacteria, I...
"Human factor" plays a crucial role in design verification ethics. Along with verification and validation, there's a term called Human Factor which me...
I completely agree with the statement @cem34 made, though the reasonings are different in my opinion. Validation doesn't signify real-time functionali...
Statistical sampling used in Control Quality. It is defined as selecting part of a population. The samples are chosen and tested according to the qual...
In many countries the design control standards are different. While in the US FDA follows ISO code regulations. On the other hand, there are different...
Design control means a specific way of planning and executing medical devices or projects. It's a combination or sum of laws. There are different part...