NegarNamdar

Forum Replies Created

RE: How to get prepare for the industry job during Ph.D. ?

Apart from internships, I’d say focus on building skills that are directly relevant to the industry you’re interested in. Things like project management, teamwork, and understanding how to apply your ...

In forum Introduction to Medical Device Development

9 months ago
RE: Multiple Regulatory Filings Process

in my opinion, yeah, harmonizing should definitely be a priority, because the sooner you get everything aligned, the less likely you’ll run into delays or compliance issues later on. But it’s also tri...

In forum Regulatory Basics for Medical Devices

9 months ago
RE: FDA rules too strict?

It’s frustrating for companies, especially smaller ones, because the cost and time involved in getting through the FDA’s process can be super high. I think there’s room for improvement in finding that...

In forum Regulatory Basics for Medical Devices

9 months ago
RE: Punishment for Failing FDA Audits

It’s totally understandable to be concerned about how minor errors can impact a company, especially when it comes to FDA audits. From what I know, even minor errors like incorrect labeling or paperwor...

In forum Regulatory Basics for Medical Devices

9 months ago
RE: Regulations in Industry vs. Academia

Industry and academic research have different regulations mainly due to their end goals. Industry follows strict guidelines like FDA's GLP since their products need to be market-ready and safe for pat...

In forum Pre-clinical Device Development

9 months ago
RE: Ensuring Biocompatibility in Medical Devices

Biocompatibility throughout a medical device’s lifecycle is super important, especially for long-term implants like joints or dental implants. Manufacturers can’t just rely on picking the right materi...

In forum Pre-clinical Device Development

9 months ago
RE: Challenges in Applying ISO 10993 Standards

One of the biggest challenges with ISO 10993 is definitely the cost and time involved in meeting all the biocompatibility requirements. Companies often struggle with figuring out the right tests, espe...

In forum Pre-clinical Device Development

9 months ago
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