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tm422
@magstiff
Trusted Member
Joined: Sep 2, 2024
Last seen: Apr 28, 2025
Topics: 1 / Replies: 78
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RE: Forming a Project Team

That's an awesome question! In order to build a successful project team, I feel that I must prioritize selecting members with the required knowledge a...

9 months ago
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RE: Expense of Regulations

Hi Savannah! Those are great questions. Compliance with ISO, FDA, and ASTM standards can be expensive as it involves a good amount of resources, exper...

9 months ago
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RE: To risk manage or not to risk manage?

Risk management is certainly a crucial aspect of the planning stage, particularly in the area of medical device development. I worked in medical devic...

9 months ago
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RE: Risk Management

Based off my experience working in a medical device company for dental implants, conducting a risk management evaluation for a medical device offers m...

9 months ago
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RE: Validation vs Verification

@jt63njit-edu I absolutely agree with you. Verification focuses on making sure that the software meets the specified requirements through activities l...

9 months ago
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RE: Consequences Of Insufficient Design Controls

Hi Saad, You make a great point that design control is crucial for any medical device development as it ensures that the item is safe, efficient, a...

9 months ago
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RE: Minutes for meetings

Hello Roberto, While I understand where Dr. Simon and many of these posts are coming from, I would like to play devil's advocate and also recount a ...

9 months ago
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RE: Corporate Responsibility?

In the world of medical devices, I would imagine that companies take corporate responsibilities pretty seriously because patient safety and following ...

9 months ago
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RE: Capstone Project Proposals (Shortened PDF)

My capstone project focuses on creating a chitosan based sulfated polysaccharide hydrogel for wound healing, specifically aimed at larger cutaneous wo...

9 months ago
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RE: The Defines of Design Controls

I agree with you that design controls are very important for ensuring the safety and efficacy in medical device development. They help in maintaining ...

9 months ago
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RE: Incentives for Clinical Trial Participants

As I worked in research with a Veterans Affairs Hospital, one major incentive outside monetary compensation that was used was access to free medical c...

10 months ago
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RE: What if I told you...

@atk27njit-edu I would disagree that the placebo effect is “all in the mind.” While the placebo effect does rely on expectation, it’s not simply a men...

10 months ago
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RE: Handling Adverse Events in Trials

Coordination during unexpected adverse events in clinical trials is absolutely essential for patient safety and maintaining the integrity of the trial...

10 months ago
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RE: Business Minor/Major

@an83 I would have to disagree on your perspective because a business minor can offer valuable skills that actually benefit a student beyond an MBA or...

10 months ago
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RE: Marketing Clinical trials And Recruitment

Some common aspects touched upon for recruiting underrepresented communities for clinical trials were building trust, making the process more accessib...

10 months ago
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