niya-j

Forum Replies Created

RE: FDA rules too strict?

I do not think the FDA is being too strict in their regulations. Their goal is to keep the general public safe from any harm from drugs, medical devices, and food. If they weren't as strict as they ar...

In forum Regulatory Basics for Medical Devices

4 years ago
RE: Discussion Topic: Quality Assurance vs. Quality Control

Posted by: @orleron Explain the difference between QA and QC, and think about the differences that each of these have as a career. For example: What types of training are relevant to each and how co...

In forum Quality Control and Quality Assurance

4 years ago
RE: Perception of QA/QC

Posted by: @mduru As with many lines of work, people tend to have a certain perception of what that field or role is like. What were some of your perceptions of QA/QC and have they changed after this...

In forum Quality Control and Quality Assurance

4 years ago
RE: Ethics of Animal Testing

Animal models are essential when attempting to see the effects of medical devices in a live system. I acknowledge that the taking of animal life may be unethical in a setting without procedures, but d...

In forum Pre-clinical Device Development

4 years ago
RE: Research for the Fututre or Now?

Both areas of research are essential for different reasons. Researching the present can be compared to what has been done for the recent COVID-19 pandemic. Rigorous research was being done to understa...

In forum Pre-clinical Device Development

4 years ago
RE: Talking about animal research

I believe a dialog between the two parties is the best solution to prevent any incidents like the destruction of research. It may benefit from having a member of these organizations on research pannel...

In forum Pre-clinical Device Development

4 years ago
RE: Thoughts on BS, MS, and PhD in BME

I agree with the idea of "more education=higher position," but sometimes that's not the case. The more I ask about careers in this field, the more I hear about the connections that helped many people ...

In forum Introduction to Medical Device Development

4 years ago
RE: Discussion Topic: Covid19 and medical devices

At the time of this post, we are still dealing with e after-effects of COVID-19's impact on the medical field. Thankfully, most manufacturers have bounced back and can produce more essentials to keep ...

In forum Introduction to Medical Device Development

4 years ago
RE: Discussion Topic: Academia vs. Industry

Academia relies on grants and academic personnel like student volunteers or other professors to continue their projects, and there is lower pay compared to industry jobs. However, the freedom of condu...

In forum Introduction to Medical Device Development

4 years ago
RE: Importance of Human Resource Management

Posted by: @devarshi-joshi The main functions of Human Resource Management department are : 1) Reduce turnover 2)Hire for fit 3)Focus on retention of top performers 5)Improve employee engagement. So ...

In forum Project Management Knowledge Areas

4 years ago
RE: Communication Management

1. I believe the PM should be in charge of developing communication and delegating who is in charge of distributing specific information to task teams. The PM should also consider the need for clarity...

In forum Project Management Knowledge Areas

4 years ago
RE: QA vs QC

Quality assurance deals with setting and perfecting metrics for quality control to following and determining whether these metrics align with the overall Quality Management Plan. In contrast, quality ...

In forum Project Management Knowledge Areas

4 years ago
RE: Factors to look for while evaluating change request

When evaluating a change request, the monitor and control team should consider the nature of the change and the long-term effects of this change if it were to be approved. Would the change benefit the...

In forum Project Management Process and Medical Device Development

4 years ago
RE: Team Development

The execution portion of a project should have days planned into the schedule to consider the vacation time of the team members. The project schedule can use some of this "cushion" of time in conjunct...

In forum Project Management Process and Medical Device Development

4 years ago
RE: project Coast

Some reasons for a budget increase on a project may include an inefficient initial design of a medical device that requires necessary revisions. Going backward and redesign an entire product for whate...

In forum Project Management Process and Medical Device Development

4 years ago
Page 2 / 4