Activity | ATMEH.NJIT | Medical Device Courses

ATMEH.NJIT liked forum post "What’s the Real Difference Between Quality Control and Quality Assurance?" – 1 week, 5 days ago

ATMEH.NJIT replied to the topic "FDA Classes: Reform needed or fine as is?" – 2 weeks, 6 days ago

I think the FDA classification system (Class I, II, and III) makes sense overall because it separates devices based on the level of risk. A simple device like a tongue depressor shouldn’t go through the same process as something like… Read more»

ATMEH.NJIT posted a new topic "Who Should Be Responsible for Regulatory Basics?" – 2 weeks, 6 days ago

In my opinion, engineers should definitely have at least a basic understanding of regulations. Even though Regulatory Affairs professionals are the ones who specialize in compliance, I don’t think engineers can just ignore it. If we design something that doesn’t… Read more»

ATMEH.NJIT posted a new topic "Should Engineers Worry About Compliance From the Start?" – 3 weeks ago

I’ve noticed that some people suggest engineers should prioritize compliance from the outset, while others believe creativity should take precedence and compliance can be addressed later. I can see both sides of this. Thinking about FDA rules early might save… Read more»

ATMEH.NJIT posted a new topic "What’s the Real Difference Between Quality Control and Quality Assurance?" – 3 weeks, 1 day ago

Sometimes people use the terms QC and QA like they mean the same thing, but I think they play different roles in device development. Quality Assurance (QA) is more about making sure the right processes are in place so mistakes… Read more»

ATMEH.NJIT posted a new topic "Are Regulations Helping Innovation or Slowing It Down?" – 3 weeks, 1 day ago

Regulations are clearly important for protecting patients, but sometimes I wonder if they also slow down new ideas from reaching the market. For example, small companies might have innovative device designs, but the cost and time required to obtain FDA… Read more»

ATMEH.NJIT liked forum post "Why Is Pre-clinical Research So Important Before Testing on Humans?" – 3 weeks, 1 day ago

ATMEH.NJIT posted a new topic "Should Companies Use Safer Materials or Take Risks With New Ones?" – 3 weeks, 4 days ago

One part of pre-clinical work that really interests me is biocompatibility. A device might be well-designed and mechanically strong, but if the body reacts badly to the material, the device will fail. Pre-clinical studies are the first place researchers can… Read more»

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