jbh8

Forum Replies Created

RE: Product Labeling

Although the damage may have been due to either party, ultimately it is the product company’s responsibility to fix the actual labeling as they are the manufacturers of the product, while the stores a...

In forum Regulatory Basics for Medical Devices

2 years ago
Multiple Regulatory Filings Process

I worked as an intern for a commercial technical operations team at a biopharmaceutical company, where some of the documentation I worked with was regulatory filings from different markets including t...

In forum Regulatory Basics for Medical Devices

2 years ago
RE: Professors in Academia

I think it is dependent on a case by case basis. In my experience, I have met professors that are inclined to research, or a combination of both. There may be a professor who is content with simply pr...

In forum Pre-clinical Device Development

2 years ago
RE: Why Are Dental Implants So Expensive?

Although a dental implant procedure may present as a simple procedure with a simple medical device, there are a few components to be considered. The implant itself has multiple comments that comprise ...

In forum Pre-clinical Device Development

2 years ago
RE: Skills to get into research

Both academic research and industry research require a few similar skills and knowledge. However, a major difference is the specificity of knowledge in a field. I believe master’s and PhD roles are a ...

In forum Pre-clinical Device Development

2 years ago
RE: FDA Consultants in medical devices projects

I agree that a FDA consultant should be included in the first project meeting. However, I believe this should also extend to other international regulatory bodies, specifically any international marke...

In forum Intro to Project Management

2 years ago
RE: How to Avoid Scope Creep

One user had previously mentioned that defining what is not within the scope would help avoiding scope creep. I agree with their point as it can ensure the team does not deviate towards any objectives...

In forum Intro to Project Management

2 years ago
RE: Due Diligence

During the initiation stage, one question I would ask myself is if there are potential ethical and social issues in regards to the product. And if so, how does the team plan to address them if possibl...

In forum Intro to Project Management

2 years ago
RE: Benefits of an academia relationship

An amicable and collaborative academia relationship can have a positive cascading effect on future students. For example, an undergraduate student joins an academic lab following their completion of t...

In forum Introduction to Medical Device Development

2 years ago
RE: Software engineering addition to Biomedical Engineering

Based on my undergraduate experience, I believe that it is dependent on the BME student’s specialization on whether they should take advanced coding techniques in different languages. It should not be...

In forum Introduction to Medical Device Development

2 years ago
RE: Changing Careers

As a high school student and college undergraduate student, I had always believed your major would define your future career path. However now as a master’s student who recently graduated with a B.S. ...

In forum Introduction to Medical Device Development

2 years ago
Page 5 / 5