Forum Replies Created
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 |
11 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 |
11 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 |
11 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 |
11 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... |
11 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... |
11 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 ... |
11 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... |
12 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... |
12 months ago | |
RE: Punishment for Failing FDA Audits @sn64 In addition to these categories, an important comment I would like to make is that "Voluntary Action Indicated" (VAI) should be taken seriously. They may not lead to recalls but rather they ref... |
12 months ago | |
RE: Professors in Academia I believe the extent of a professor's passions in academia and research depends on the individual professor, but often professors have a mix of these motivations. I have had professors who have been d... |
In forum Pre-clinical Device Development |
12 months ago |
RE: Regulations in Industry vs. Academia I have been working as an intern in industry research for the last couple months and what I can gather is that it is generally heavily regulated by agencies like the Food and Drug Administration (FDA)... |
In forum Pre-clinical Device Development |
12 months ago |
RE: Challenges in Applying ISO 10993 Standards There are many hurdles that companies face when attempting to align themselves with ISO 10993's biocompatibility principles. First, medical devices are often made with complex materials to enhance the... |
In forum Pre-clinical Device Development |
12 months ago |
RE: Which feature is the most important for a project manager? Out of the qualities listed, I believe that personal organization is the most essential feature for a project manager. As the previous posts expressed, communication and negotiation are critical howev... |
In forum Intro to Project Management |
12 months ago |
RE: FDA Consultants in medical devices projects Hi Jafar, I absolutely agree that having FDA Regulatory Consultant in medical device projects is essential. Medical devices are subject to strict regulations due to their requirements regarding patien... |
In forum Intro to Project Management |
12 months ago |