agebraeil

Forum Replies Created

RE: Emerging technologies and QA

I think technology is always evolving and it is doing so rapidly so I do believe that QA should adapt to the rapidly changing technology. Tools like AI can be beneficial in making processes go faster ...

In forum Quality Control and Quality Assurance

2 days ago
RE: What’s the Real Difference Between Quality Control and Quality Assurance?

I think that both quality assurance and quality control are crucial for patient safety. QA is important because it focuses on preventing issues before they happen. Through training, QA establishes cle...

In forum Quality Control and Quality Assurance

2 days ago
RE: Relation of Quality with other department.

I think the most efficient way for quality teams to collaborate with R&D teams would be for both teams to communicate with each other consistently. I think quality teams should be involved in the ...

In forum Quality Control and Quality Assurance

2 days ago
RE: Does the FDA guarantee safety?

This is a good question that is difficult to answer. I do not think that FDA approval means a drug or device is risk free. There have been many drugs that have been approved and put out on market but ...

In forum Regulatory Basics for Medical Devices

7 days ago
RE: FDA on Recalled Items

A product that was recently recalled is Zantac. This is a heartburn drug and it was recalled in 2019 because of a cancer causing chemical called NDMA. This became clear after testing when it was in ma...

In forum Regulatory Basics for Medical Devices

7 days ago
RE: Should Engineers Worry About Compliance From the Start?

I think the best thing to do depends on the project and whether or not it's a small startup or a larger company. For small startups, I think it makes sense to focus on the innovation first which allow...

In forum Regulatory Basics for Medical Devices

7 days ago
RE: Why Is Pre-clinical Research So Important Before Testing on Humans?

I agree, preclinical research is crucial in making sure the safety before going through human trials. This is especially true for medical devices that could be a serious threat if something goes wrong...

In forum Pre-clinical Device Development

2 weeks ago
RE: Key factors to consider while selecting appropriate animal models for pre-clinical research to develop therapies for neurological disorders.

I agree that choosing the correct animal model is crucial in research especially in neuroscience. Due to the brain being complex, using models that are close to human biology can improve the accuracy ...

In forum Pre-clinical Device Development

2 weeks ago
RE: Research for the Fututre or Now?

I think that both short and long term research have value. I believe that research that helps people right away is more beneficial. It allows the researchers to see how their work has improved people'...

In forum Pre-clinical Device Development

2 weeks ago
RE: Milestones Missed: Failure or Success?

Missing a milestone is a failure, if you have a deadline you should be able to meet it if you are managing your time correctly. Being diligent of a milestone is important especially in the industry be...

In forum Intro to Project Management

3 weeks ago
RE: Exceeding the budget

It is crucial that the project manager deals with budget concerns by evaluating where all the costs can be allocated. When exceeding the budget, it is important that the project manager evaluates wher...

In forum Intro to Project Management

3 weeks ago
RE: Prioritizing tasks while managing multiple projects simultaneously

I think that having a timeline when it comes to project management is crucial in ensuring an effective project. I believe that you need to prioritize all tasks efficiently and in a smart way. A timeli...

In forum Intro to Project Management

3 weeks ago
RE: Medical Device Certification

I do think that medical device certification is an important step in the process of development even if it is not a main focus. I do believe that it is a useful certification to have considering when ...

In forum Introduction to Medical Device Development

4 weeks ago
RE: Is AI going to control the medical Industry ?

I do not believe that AI is going to control the medical industry but I do think it is going to change it. I believe that AI has the potential to affect the industry efficiently but it is not able to ...

In forum Introduction to Medical Device Development

4 weeks ago
RE: Medical Device News

I think AI is one of the biggest improvements in the medical device industry. I believe that it can be used to improve accuracy and personalize treatments more efficiently. I have read that AI can ide...

In forum Introduction to Medical Device Development

4 weeks ago
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