Posted by: @jaf22 Consultants in my company or my previous company have been useful in bringing expertise where our group lacks or needs a third party view. For instance, my company had a large acqui...

In this week's lecture, Dr. Simon mentioned some laws which restrict physicians to receive gifts from companies. The laws are Anti-kickback Statutes and Advamed Guidelines. I agree with Naglaa. I am...

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 out the terms of the agreement which limits any of...

I do have different opinions than @naglaa. For startup medical device companies I would highly recommend matrix organization over functional and project-based organizations. In functional organization...

We have known from Dr. Simon's lecture, upper management is strategic, while middle management is tactical. Upper management is concerned with the growth of organization in the upcoming years, while t...

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 formed based on the employee's skillsets, availabi...

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 been mentioned. Among them first one was FMEA. FMEA s...

Though risk management certainly has some advantages and benefits, there are some disadvantages too. If we think about automated risk management information systems that will make my statement more cl...

Since there are two types of risks involved, their difference would enable us to solve them. Cost risk, schedule changes, performance and quality risk are listed as internal risks. Cost risk means ris...

I would like to talk about the verification protocol imposed by FDA on Surgical masks. Inadequate fluid resistance, Inadequate barrier for bacteria, Inadequate air exchange (differential pressure), Fl...

"Human factor" plays a crucial role in design verification ethics. Along with verification and validation, there's a term called Human Factor which means, evaluating a device’s user interface to confi...

I completely agree with the statement @cem34 made, though the reasonings are different in my opinion. Validation doesn't signify real-time functionality rather it ensures the efficacy of a product bas...

Statistical sampling used in Control Quality. It is defined as selecting part of a population. The samples are chosen and tested according to the quality management plan. When doing this particular pr...

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 standards settled by other countries. Though ther...

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 parts of the design process. Each part can have detail...