Both structures definitely have their pros and cons, and I think the choice really comes down to the business’s growth plans and funding needs. For sm...

These are all great points, and I’d also add that building strong relationships with customers, vendors, and partners plays a key role in long-term su...

These are great points. I’d just add that LLCs are usually the go-to for entrepreneurs because of their simplicity and flexibility, especially for ow...

Regulatory Affairs is an interesting field, and while I haven’t worked in it myself, I know that it plays a vital role in bridging the gap between com...

I agree that audits, both internal and external, play a crucial role in ensuring that QA and QC follow proper protocols. It"s interesting how QA is ob...

These are great points. I completely agree that having a diverse panel with a range of expertise is critical for thoroughly evaluating novel products....

These are good points about post-market surveillance and the UDI system. I agree that regulatory compliance doesn't stop at FDA approval- it's an ongo...

I couldn't fully follow along with the most recent comment on this thread because it was pretty lengthy without any paragraph breaks. As for the other...

These are great points about the FDA’s challenge of balancing safety with innovation, especially when it comes to combination products. The blurred li...

These are some good points raised about the complexity of material characterization and variability in biological responses. I agree, the challenges a...

These are all great points, and I would also add that the role of regulatory consultants becomes even more critical as device complexity increases. Fo...

I agree with the points made earlier about the high costs being influenced by the materials, expertise, and precision required for dental implants. As...

Balancing scope and innovation is definitely challenging, especially in medical device development where timelines and regulations are strict. I think...

Variance does give us insight into whether a project is ahead or behind schedule, but it can also serve as a signal for deeper issues. For instance, c...

I agree that while a PM in biomed engineering doesn't need deep technical knowledge, having a solid grasp of the basics is crucial. One thing I'd add ...