gp232@njit.edu

Forum Replies Created

RE: Written Agreement v/s Verbal Agreement

Although it may sound easy to recommend an agreement be written versus oral, sometimes time does not allow this to happen and does not allow every agreed upon aspect included in the contract. For ins...

In forum Consultants and Legal Basics

8 years ago
RE: Forming a Project Team

In response to the first post, I believe it is better for teams to work with people who are knowledgeable in their department roles. I would avoid assigning people to teams who I know have a bad hist...

In forum Organizational Development in Device Companies

8 years ago
RE: Organizational structure and Culture both leading to project success?

I have to disagree with the first post that organizational culture plays a significant role in the creation of work environment, ethics, and the view of authority. I believe the best teams can be est...

In forum Organizational Development in Device Companies

8 years ago
RE: Organizational Behavior Management

Several factors impact organizational performance such as culture, motivation, decision making, and change management. Each of these factors impact organizational behavior differently. I would say o...

In forum Organizational Development in Device Companies

8 years ago
RE: Risk Management Mistakes

I agree that risk management is a “checkbox” activity to some companies. Just like quality control and quality assurance, risk management is important to producing a safe product built of high qualit...

In forum Risk Analysis for Medical Devices

8 years ago
RE: Risk Management - Identification

I identify risks from high to low and everything in between. I believe managing risk is a balancing act which takes time and skill to master. What you may not perceive is a high risk and miss-catego...

In forum Risk Analysis for Medical Devices

8 years ago
RE: Manage Risk

Dhairya, For low severity of risk I would choose acceptance. If a risk is acceptable, it should be low by default. High risk items should be mitigated down to a medium or low risk whenever possible....

In forum Risk Analysis for Medical Devices

8 years ago
RE: Minutes for meetings

Roberto, Meeting minutes may not seem important until you need them. In one case, I was in a meeting where I was aware of what was said and agreed to but did not remember the specific date and person...

In forum Introduction to Design Controls

8 years ago
RE: Design Review Meetings

Himang, I don’t have personal experience with design review meetings however; I have a friend who has some experience in such meetings. The design review process itself could happen in stages. As yo...

In forum Introduction to Design Controls

8 years ago
RE: Discussion Topic: Supplemental on DHF and DMR

Design controls may not be required for Europe, however they can come in very handy with the Design Dossier or Technical File. Logging the development process is good practice and should be done rega...

In forum Introduction to Design Controls

8 years ago
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