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at644
@at644
Active Member
Joined: Sep 1, 2025
Last seen: Sep 28, 2025
Topics: 1 / Replies: 11
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RE: Combination Product

Nasal spray is a combination product because a drug is prepackaged in a delivery system that enters the nose. The pump can be specialized to deliver a...

3 days ago
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RE: How to start career in regulatory area (no industry exp yet)

People in medical device regulations need to handle changes set by different regulatory bodies. Many companies also want to sell abroad or work with o...

3 days ago
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RE: FDA Classes: Reform needed or fine as is?

In terms of general reform or changes, what came to mind was the Medical Device Amendments of 1976. Similar medical devices already sold in the countr...

3 days ago
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RE: Stability testing importance

Medical containers and trays that are used to store surgical instruments benefit from stability testing. The regulatory requirements for these medical...

2 weeks ago
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RE: Ensuring Biocompatibility in Medical Devices

Another aspect to consider when preventing adverse reactions is proper placement of the medical implant by the medical professional. Adequate medical ...

2 weeks ago
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RE: Pitching Research in Industry vs. Academia

I have some industry experience in a small laboratory setting. What I did to expedite the progress was online research because I did not have much kno...

2 weeks ago
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RE: Quality and Risk Management in the Project Life Cycle

Conducting preclinical studies is beneficial in risk identification and evaluation during project development. Many of the processes in industry need ...

2 weeks ago
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RE: Managing Team Opinions While Sticking to Decisions

This post highlights the significance of project roles, especially the project leader or manager role. A project leader may also be a stakeholder, or ...

3 weeks ago
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RE: Project Management Apps

The planning phase of project management determines the required tasks in order typically using a work breakdown structure. Depending on the project, ...

3 weeks ago
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RE: Is AI going to control the medical Industry ?

AI can be a useful tool in the medical device industry if used appropriately. I hope that AI can continue to drive sustainability efforts in the healt...

4 weeks ago
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RE: Academia vs. Industry: Why I Prefer Industry

I prefer the industry sector of biomedical devices because that is where my experience is. Depending on the nature of the person, the academic or the ...

4 weeks ago