This is an interesting question! I agree with most of the participants that depending on the device classification, EU regulatory looks at the device development in the Tech File. While, in the US, ...

In Undergraduate Biomedical Engineering Curriculum at NJIT, students are required to take the Capstone (Senior Design Project) Class. If the project involves testing on human subject, an IRB approval...

This is an interesting question! I agree with most of the participants that having clinical background is a plus, but again it depends on the type of role within the CRA profession. For example, Sta...

I agree with most of the participants in the forum that clinical studies/trial comes with a risk and a side effects. However, it is crucial for the researchers and doctors to perform these clinical t...

This is an interesting question. In my opinion, when recent graduates apply for the positions in the related field, they do not necessarily look whether the company is Limited Liability Company vs Cor...

If given the choice to open my own business, I would file my business as Limited Liability Company (LLC) over a Corporation. There are many reasons in terms of Taxes, Business Ownership, and Business ...

Privately owned companies are privately held. This means that the company is owned by small group of people, or private investor. On the other hand, in public company, there are shareholders that clai...

Privately owned companies are privately held. This means that the company is owned by small group of people, or private investor. On the other hand, in public company, there are shareholders that cl...

This is an interesting question. In my opinion, when recent graduates apply for the positions in the related field, they do not necessarily look whether the company is Limited Liability Company vs Co...

If given the choice to open my own business, I would file my business as Limited Liability Company (LLC) over a Corporation. There are many reasons in terms of Taxes, Business Ownership, and Business...

Many departments such as Manufacturing or R&D tends to complaint that their quality department is so stringent in terms of documentation and the document control even if it means to delay product ...

This is a great question. Prior to FDA or BSI audit, the quality department of the company prepares for the audit in gathering few DHRs (Device History Records). From the auditor’s perspective, he/s...

I agree with most of the participants in terms of the importance of Quality Department in a medical device industry. I’ve worked as a Quality Engineer for 2 years in a medical device company and I’ve...

Recently, in the April of 2017, Zimmer Biomet recalls Implantable Spinal Fusion Stimulators due to potential of harmful chemical which may be toxic to the tissues and organs. FDA has classified this ...

What do you think of the new Trump's 2018 budget proposal of $2 billion increase in FDA User Fees for medical device registrants for 2018? Will this have an impact on the use of de novo 510k Process?...