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mglassen
@mglassen
Eminent Member
Joined: Sep 8, 2024
Last seen: Dec 1, 2024
Topics: 0 / Replies: 39
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RE: Advamed Guidelines

I think a reasonable location has to be somewhere where the main purpose is the meeting itself, with no other unrelated benefits. So places like meeti...

3 months ago
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RE: Advice before signing an NDA

While there are a few things I would want to know before signing an NDA, I agree with other posters that they are not something to be avoided at all c...

3 months ago
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RE: Written Agreement v/s Verbal Agreement

The obvious reason for choosing a written contract over a verbal one is that verbal contracts are more challenging to defend or enforce in court, but ...

3 months ago
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RE: Seniority and Old Habits Vs. Newbies and New Techniques

I think going above your management to senior management is usually a bad idea, and can engender negative work environments. If you believe as a manag...

3 months ago
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RE: Forming a Project Team

I think keeping everyone talking and in communication can be a great benefit to a project team. Having a once a week meeting, even just for 30 minutes...

3 months ago
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RE: Desicion made by one person

I think one person having decision making powers can be a bonus when kept to specific, time-limited scenarios. When the person making decisions has lo...

3 months ago
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RE: Residual risk during device development

I think the greatest tool you have in this case is historical data. In most cases, unless your product is truly revolutionary, there should be at leas...

4 months ago
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RE: Risk Acceptance

I don't think acceptance changes the probability of risk in a situation. I believe it just means that you are ok with that probability combined with t...

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

Learning about all the different fields in medical device development so far, I have seen a large overlap in responsibilities between the different te...

4 months ago
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RE: Validation Study Success Defined

Literature research can be a big help in designing success criteria for a study. Looking at similar successfully released products can provide a great...

4 months ago
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RE: Effective Use of Design Transfer in Streamlining Production for Medical Devices

The Design Transfer Document is the answer to the first question. As long as all inputs/outputs are exhaustively documented, production errors should ...

4 months ago
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RE: Minutes for meetings

Design minutes, while often ignored, I think are a very valuable tool. For one, they help to ensure accountability. If minutes are kept, they can alwa...

4 months ago
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RE: Benefits of Software Validation

Software validation is a great feature that can help in many ways. One big help is in customer satisfaction, if the software for a product works as ex...

4 months ago
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RE: Consequences Of Insufficient Design Controls

As mentioned in the lecture, some companies do not take Design Control seriously, and instead create these documents as an afterthought, and just fit ...

4 months ago
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RE: Design "Overvalidation"?

While it is certainly possible to overdue it, I think logging more inputs then you think you will need is a smarter way to go then just logging the ba...

4 months ago
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