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njq3
njq3
@njq3
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Joined: Jan 21, 2022
Last seen: Dec 4, 2022
Topics: 5 / Replies: 48
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RE: Contract Law components examples

Intention to create legal relations essentially means that both parties are agreeing to enter a legally binding contract. This is obviously important ...

2 months ago
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RE: Discussion Topic: Course conclusion and impressions

I enjoyed seeing the comparisons between a career in academia vs. a career in industry. I currently work in industry, but it was neat to see the pros....

2 months ago
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RE: Confidentiality Agreements

I think it's important to discuss the responsibilities of the consulting firm in the agreement and ensure that all expectations are crystal clear. Of ...

2 months ago
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RE: Getting Everyone's Input in Risk Management Meetings

I do not work in medical device industry but our company holds risk assessment meetings for any type of change (change control) or new project coming ...

2 months ago
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RE: Risk Management Team =/= Project Team

Hypothetically, if you have a project team who is really pushing to get their product on the market or are pressured by deadlines in industry, having ...

2 months ago
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RE: Gantt Chart Thought Process and Considerations

I don't have experience using Gantt charts myself in my current career but I have worked with engineers/project managers that use Gantt charts for the...

3 months ago
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RE: Design Controls Component

For me, I am most interested in the planning, verification and validation process. I think the verification and validation steps are where you do the ...

3 months ago
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RE: Different Standards for Design Controls

I believe companies do all sorts of analyses to understand what the best approach is to adhere to the standards posed in ISO 13485 and 21 CFR 820:30, ...

3 months ago
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RE: Design Specification document

One example of a product that probably we have all seen before that would have a design specifications document is an otoscope. An otoscope is a tool ...

3 months ago
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RE: Design Control Job Roles

I do not currently work at a medical device company but I work a cosmetic manufacturing plant that employs roles in QA, QC, and project managers that ...

3 months ago
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RE: Good Clinical Practices within Job Roles

I think one of the most common careers where GCP is involved is "Clinical Research Associate". I think this has come to mean in general, someone who i...

3 months ago
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RE: Sales vs project management

While the two areas are very different and deal with different scenarios, I think the information exchange between the two departments needs to be ver...

3 months ago
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RE: The Four P's

I feel that all 4 of these P's need to work in unison in order to truly market a product towards a successful lifecycle so it's hard to single one out...

3 months ago
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RE: Branding as an Engineer

I have had no previous experience in branding or graphic design, but I have felt that I think I have an eye for what looks good or what looks pleasing...

3 months ago
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RE: Auditing Bodies

In addition to the poster above - there may be changes in regulations when transitioning to MDSAP. Because the program is now including at least 5 dif...

4 months ago
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