Engineers can leverage their technical expertise in customer-facing contexts through sales and marketing roles in the medical device business. These p...

If I were starting my own business, I would specialize on designing cutting-edge biorobotic prosthesis for people with mobility problems. My company w...

I agree with both participants that medical device marketing techniques must adapt, especially with technology and engineering. Building on this, the ...

While it's clear that nonprofit organizations focus on public benefit, and the cost structure for a medical device or pharmaceutical company presents ...

Interesting points, everyone. While I agree that a sole proprietorship isn’t a corporation, it’s crucial to highlight that the key difference stems fr...

I agree that FDA advisory committees must consist of a variety of experts; yet, I would also add that manufacturing and regulatory considerations are ...

Regarding the need of quality assurance (QA) and control, everyone has raised excellent arguments. Furthermore, I believe that one can't overlook the ...

Maintaining system interoperability with third-party applications is another difficulty when switching ERP/QMS systems. Integrating specialized soluti...

You’ve highlighted important aspects of the FDA and CDRH’s roles in regulating medical devices. One additional point to consider is the significant ro...

I agree that harmonizing regulatory filings is essential, and building a core dossier is an effective approach. One challenge not yet mentioned is the...

I agree with your points about the FDA's role, and I think another significant challenge is the complexity of regulating combination products, like dr...

Absolutely, I agree that regulatory consultants play an invaluable role in guiding companies through the complex landscape of medical device developme...

The regulatory environments for pre-clinical research in industry versus academia exhibit notable differences driven by their end goals and the nature...