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hruship101
@hruship101
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Joined: Jan 27, 2017
Topics: 8 / Replies: 68
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RE: Written Agreement v/s Verbal Agreement

This is a really interesting topic to discuss. There are many pros and cons of having a written agreement versus verbal agreement. Many medical devi...

7 years ago
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RE: Discussion Topic: Course conclusion and impressions

I agree with all of the participants in this post regarding Dr. Simon’s class. This is my second semester as Masters in Biomedical Engineering and al...

7 years ago
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RE: Forming a Project Team

This is a really interesting question! In order to successfully complete a project on time, project team must collaborate at a defined frequency and ...

7 years ago
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RE: Discussion Topic: Your organizational type

I believe my organization is consider to be Matrix Organization, but also overlaps with the functional organization. We have a CEO, followed by Group...

7 years ago
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RE: Risk Identification

My company also uses the FMEA (Failure Modes Effects Analysis) technique to evaluate the risk associated with the medical device or production process...

7 years ago
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RE: Risk management and Labels

This is an interesting topic for discussion! I agree with Dr. Simon that labeling or putting a warning on the package is not a direct way of mitigatin...

7 years ago
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RE: Discussion Topic: Risk Management, Risk Analysis

I agree with most of the participants on the above post. ISO 14971, major regulation detailing the Risk Management Requirements for Medical Devices. ...

7 years ago
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Replies: 6
Views: 1313
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RE: How to ensure your DHF is audit ready ?

This is an interesting discussion topic! In the medical device industry, it is very critical to have the most up to date DHF as the project moves for...

7 years ago
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RE: Customer Needs, Business Requirements, Test Plan

I agree with most of the participants in the above posts. During my senior design class at NJIT, I learned more about the requirement and the test me...

7 years ago
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RE: Design Review Meetings

I do not have an experience with design review meetings in the industry, but I will share my experience participating in the design review meeting for...

7 years ago
Topic
Replies: 9
Views: 1420
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RE: Discussion Topic: Supplemental on DHF and DMR

This is an interesting question. I agree with most of the participants that depending on the device classification, EU regulatory looks at the device...

7 years ago
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