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Scott
@savery115
Trusted Member
Joined: Dec 28, 2016
Topics: 11 / Replies: 71
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RE: career path

I agree with a lot of the post above in regards to the amount of paperwork that potentially needs to be done within this field. I don't have experien...

6 years ago
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RE: Simulation Experience

The simulations were very helpful because it teaches you different ways to think outside the box in terms of resolving different issues from a very ba...

6 years ago
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RE: AMDD

MDD and AMDD are very good classes to get your feet wet in understanding the different aspects of medical devices and what can lie ahead in your engin...

6 years ago
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RE: Significant risk vs Non-significant Risk

In agreement with this. You can have two similar functioning products but have different risk. An implantable suture that biodegrades into the body wo...

6 years ago
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RE: Unexpected Clinical Study Results

I agree with this point. Failed clinical trials is bad press for a company. Articles usually pop up when a company's clinical trials fail for a medi...

6 years ago
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RE: Clinical Study Location/cost vs. results

Outside of the budget and resource issues that others above have pointed out, it would be interesting to consider conducting a clinical study dependin...

6 years ago
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RE: No GMPs

I don't necessarily agree that having zero GMP will lead to lower cost in anything. I'm not sure what type of buyer would want to purchase any produc...

6 years ago
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RE: Management Responsibility

This is a very good observation. Contracting employees has long been a solution for big medical device companies to control budget constraints. The ...

6 years ago
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RE: CAPA

I agree with this. CAPAs are meant to self correcting actions that a quality system intakes to ensure products and processes are in conformance. I w...

6 years ago
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RE: Discussion Topic: Vagueness of GMP's

In agreement with this. The ambiguity for GMPs established within a start-up opens itself for improvement and new policies that will, in turn, reduce...

6 years ago
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RE: Non-Conformity

At my company most non-conforming issues usually stem from either operator mistakes or product not conforming to QC testing. When non-conforming issu...

6 years ago
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RE: Discussion Topic: When Quality Systems change in the middle of a project

Grandfathering a project due to changes in a quality system usually consider the following components: project scope (ex. changes to processes, docum...

6 years ago
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RE: Simulation 3

From my experience if sales numbers are lagging, there needs to be a way to compensate that by finding ways to SAVE money. Usually if sales at my com...

6 years ago
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RE: Emotional intelligence in negotiations

Emotional intelligence is highly important in negotiations. I believe this is one of the few things that is difficult to teach as emotional intellige...

6 years ago
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RE: Innovation and Discovery Hurdles

I believe I can relate to this. I have noticed that engineers in a leadership role for an extended period of time within a company, can at times, get...

6 years ago
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