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mglassen
@mglassen
Eminent Member
Joined: Sep 8, 2024
Last seen: Dec 2, 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...

9 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...

9 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 ...

9 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...

9 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...

9 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...

9 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...

9 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...

9 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...

9 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...

10 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 ...

10 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...

10 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...

10 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 ...

10 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...

10 months ago
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