anhtong

Forum Replies Created

RE: Advice before signing an NDA

The most valuable asset that every business has is its secrets. In this era where your competitor can get your secrets and outsmart you in performance, NDAs come in handy. They provide protection in t...

In forum Consultants and Legal Basics

7 years ago
RE: Restrictions for physician's gifts

This is a good question for discussion, Roberto. I agree with zmh4 that if two people are out to discuss business, then it should only be about business. However, some issues can come up, and an uninv...

In forum Consultants and Legal Basics

7 years ago
RE: Written Agreement v/s Verbal Agreement

I agree with cef3 that verbal contracts are difficult to defend in courts in case a dispute comes up between the two parties to an agreement. This, however, does not mean that verbal contracts are not...

In forum Consultants and Legal Basics

7 years ago
RE: Collaboration projects

I agree with smk45 that matrix organizational structure is the most ideal for collaboration projects. Staffers in a matrix organizational structure report to a product line manager and a functional ma...

In forum Organizational Development in Device Companies

7 years ago
RE: Effective way to culminate inter department silos

Silo mentality refers to a mindset present when sectors or departments are not willing to freely share information with other members in the same organization. It is not a coincidence that most organi...

In forum Organizational Development in Device Companies

7 years ago
RE: Organization Type vs. Effectiveness

I agree with Anthony Monaco that the choice of an organization structures depends on the size of the company. I must also add that the type of structure chosen also depends on the aims and the type of...

In forum Organizational Development in Device Companies

7 years ago
RE: Risk Management - Identification

I agree with ds654 that the full project team should be actively involved in the process of risk identification and that every contribution of each member should be well-documented whether other membe...

In forum Risk Analysis for Medical Devices

7 years ago
RE: Expense of Regulations

This is a pretty good topic for discussion, sdl3. You see, these regulations are developed by other companies to help others be compliant. They are basically doing a service to others companies by ens...

In forum Risk Analysis for Medical Devices

7 years ago
RE: How to run a risk management meeting ?

I agree with markabdelshahed that a risk management meeting starts with the project manager sending a meeting invitation to all the attendees ahead of time so that they prepare themselves adequately f...

In forum Risk Analysis for Medical Devices

7 years ago
RE: Why VERIFICATION is important? and Your ideas to improve Verification process ?

Verification is the process of ensuring that objective evidence are present and that the specific requirements are met. This process is usually done by inspections, tests, and in some instances analys...

In forum Introduction to Design Controls

7 years ago
RE: Design Review Meetings

I agree with you that design meetings facilitate communication between the parties involved such as management, design team, and the customer. Although I don’t have experience with design review meeti...

In forum Introduction to Design Controls

7 years ago
RE: Consequences Of Insufficient Design Controls

One of the most problems common with design controls is that medical devices companies put emphasis on following the regulation rather than understanding the intent. For instance, some of the regulati...

In forum Introduction to Design Controls

7 years ago
RE: Minutes for meetings

I agree that meetings are important, but often many people do not see their importance. Taking minutes in a meeting requires skill, especially since the minute taker has to follow what the people in t...

In forum Introduction to Design Controls

7 years ago
RE: Factors to Consider While making Gantt Chart

Gantt Charts are useful in this industry, particularly since they describe and monitor all types of projects being carried out. I agree with your bullet points about the factors to put into considerat...

In forum Introduction to Design Controls

7 years ago
RE: How to ensure your DHF is audit ready ?

A Design History File (DHF) is part of a regulation that established new standards for medical devices. In the event of an audit by a regulatory body, you will need to provide information from the DHF...

In forum Introduction to Design Controls

7 years ago
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