tm422

Forum Replies Created

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 the structural approach that aligns with FDA requi...

In forum Introduction to Design Controls

5 months ago
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 care or treatments. The offer of free medical evalu...

In forum Clinical Research Basics

6 months ago
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 mental trick played by the mind. This is rather a rea...

In forum Clinical Research Basics

6 months ago
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. A standardized, predefined process for assigning...

In forum Clinical Research Basics

6 months ago
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 entry level role. An undergraduate education does...

In forum Marketing and Sales

6 months ago
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 accessible, and ensuring the message has some form of rela...

In forum Marketing and Sales

6 months ago
RE: Is entering a career in sales worth it?

The original poster brings up a good point about the marketing engineer role, especially in the medical device industry, as this career path blends technical expertise with the need of strong interper...

In forum Marketing and Sales

6 months ago
RE: First Job: What type of company to choose?

@tamanna While I agree with you that working in a smaller company can offer valuable exposure to multiple areas, I would also like to make note of the downside that being spread too thin across multip...

In forum Business 101

6 months ago
RE: Non for profits

Having volunteered at a tissue bank before, I see that non profit tissue banks are playing a critical role in public health by focusing on service rather than profit. My favorite aspect about non prof...

In forum Business 101

6 months ago
RE: Difference between type of company to work for and to start

After working with a couple medical device companies, I believe my top requirements do not depend on the notion of public or private, but rather the entirety of benefits offered to me. First, I person...

In forum Business 101

6 months ago
RE: Items Affecting Quality

I appreciate that the original topic starter had mentioned thinking from the patient’s point of view. I believe this is a highly important notion for the medical device industry. There are standards s...

In forum Quality Control and Quality Assurance

6 months ago
RE: FDA Advisory Panel Members with QC/QA Background

@fh28 I agree with your perspective on the importance of diversity as well as varied expertise on an FDA expert panel! This is crucial as each member brings a different background to the evaluation, a...

In forum Quality Control and Quality Assurance

6 months ago
RE: Issues with the Quality Department

The most common problem I face as a quality engineer intern are challenges due to document control. In other words, updating procedures, specifications, and records among different teams and ensuring ...

In forum Quality Control and Quality Assurance

6 months ago
RE: Product Labeling

@dmf2 I respectfully disagree with the notion that the primary responsibility for addressing a damaged label should fall on the store. In my point of view, I believe that the manufacturer is 100% resp...

In forum Regulatory Basics for Medical Devices

7 months ago
RE: Regulatory Department Functions

Although it is tempting for me to say that post-market management is where the issues arise, I would argue that product development is the single most critical phase in determining a project's success...

In forum Regulatory Basics for Medical Devices

7 months ago
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