Forum

Rifath Hasan
Rifath Hasan
@rifath-hasan
Eminent Member
Joined: Sep 3, 2021
Last seen: Nov 28, 2021
Topics: 0 / Replies: 24
Reply
RE: Consultants in the Medical Device Industry

Though filling up a void position temporarily is an advantage of hiring consultants, there are many other strong benefits of having consultants. Medic...

1 year ago
Reply
RE: Restrictions for physician's gifts

In this week's lecture, Dr. Simon mentioned some laws which restrict physicians to receive gifts from companies. The laws are Anti-kickback Statutes ...

1 year ago
Reply
RE: Written Agreement v/s Verbal Agreement

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 ...

1 year ago
Reply
RE: Organization types of medical devices?

I do have different opinions than @naglaa. For startup medical device companies I would highly recommend matrix organization over functional and proje...

1 year ago
Reply
RE: Traits of upper management versus middle management

We have known from Dr. Simon's lecture, upper management is strategic, while middle management is tactical. Upper management is concerned with the gro...

1 year ago
Reply
RE: Forming a Project Team

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 ...

1 year ago
Reply
RE: Implementing a risk management plan

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...

1 year ago
Reply
RE: Risk Management

Though risk management certainly has some advantages and benefits, there are some disadvantages too. If we think about automated risk management infor...

1 year ago
Reply
RE: Two Types of Risk

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

1 year ago
Reply
RE: Verification Protocol

I would like to talk about the verification protocol imposed by FDA on Surgical masks. Inadequate fluid resistance, Inadequate barrier for bacteria, I...

1 year ago
Reply
RE: Design Verification Ethics

"Human factor" plays a crucial role in design verification ethics. Along with verification and validation, there's a term called Human Factor which me...

1 year ago
Reply
RE: Validation vs Verification

I completely agree with the statement @cem34 made, though the reasonings are different in my opinion. Validation doesn't signify real-time functionali...

1 year ago
Reply
RE: Statistical Sampling

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...

1 year ago
Reply
RE: Design Controls in the other countries

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...

1 year ago
Reply
RE: What are Design Controls?

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...

1 year ago
Page 1 / 2