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mmodi
mmodi
@mmodi
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Joined: Jan 18, 2022
Last seen: Dec 3, 2022
Topics: 2 / Replies: 79
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RE: Controversy regarding Advamed Guidlines

Prior to this lecture I had never learned about the AdvaMed Code of Ethics. For those unfamiliar with the topic, the AdvaMed Code of Ethics outlines g...

2 months ago
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RE: NDA vs Patents

A non-disclosure agreement (NDA) is a legally enforceable agreement between individuals or parties that ensures information which will be discussed or...

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

As per the responses from my peers, all businesses require contracts. As per this weeks lecture, contracts must demonstrate the capacity and intention...

2 months ago
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RE: Organizational structure and Culture both leading to project success?

Organizational culture is a system of shared values, norms, and beliefs that are internally and externally promoted. An organization's culture typical...

2 months ago
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RE: Forming a Project Team

I believe a successful project team must have a diverse set of skills and experiences in order to complement one another in areas that ones' peers may...

2 months ago
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RE: Discussion Topic: Your organizational type

As per the PMBOK Guide, there are eight types of organizational structures seen when running a business: organic, functional, multi-divisional, matrix...

2 months ago
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Replies: 3
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RE: Benefits of post-market surveillance

Post-market surveillance is the practice of monitoring medical devices as well as taking reactive and proactive actions once the equipment is sold and...

2 months ago
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RE: Dealing with risk

As someone who works primarily on post-market surveillance of medical imaging equipment, it is my responsibility to determine the root cause when a sy...

2 months ago
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RE: Design Verification & Validation vs Clinical & Pre-Clinical Trials

I believe only conducting verification and validation studies is acceptable for a class I medical device or a class II medical device that is substant...

3 months ago
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RE: What FDA Looks For In A Design Control System ?

It is important to note that design controls are just a singular subpart that are reviewed to ensure compliance with quality system regulations. Desig...

3 months ago
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RE: Consequences Of Insufficient Design Controls

As per the responses from most of my peers, without clear design controls the project timeline will continuously have to be modified and updated as ne...

3 months ago
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RE: Design Specification document

Upon reading through responses from my peers, this seems like really fun thread to respond to. Another example of a medical device with important desi...

3 months ago
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RE: Design Controls: What do you deem most important?

As we discussed, there are nine design controls listed in 21 CFR 820.30 which include planning, input, output, review, verification, validation, trans...

3 months ago
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