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JOnyekwere
@jonyekwere
Eminent Member
Joined: Jul 2, 2019
Last seen: Aug 24, 2019
Topics: 0 / Replies: 25
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RE: Your Organizational prference; but why?

Given the work that I do, I think the functional organization is the structure in which I would prefer to work. My organization is headed by a chief e...

5 years ago
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RE: Non Compete Agreement

From what I have observed during my time working in the medical device industry, non-competes do have an effect on those looking for jobs with rivals....

5 years ago
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RE: NDA vs Patents

An NDA is not a substitute for a patent. Patents offer protections for IP, products, and services that far exceed the the protection from disclosure o...

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

ISO 14971:2007 is the major regulation governing risk management. The major risk management requirements for a medical device company include the impl...

5 years ago
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RE: how far is "As Far As Possible"

I agree that AFAP represents a gray area, though that may perhaps be by design. Many of the standards are intentionally vague to allow flexibility to ...

5 years ago
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RE: Risk management and Labels

On the company's end, things they can do for risk management outside of printed warnings include designing out the risk, implementing safeguards, and ...

5 years ago
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RE: Discussion Topic: Quality Assurance vs. Quality Control

My work in the regulated production setting refers back to my time spent as a clinical chemist in a high-complexity toxicology laboratory, not my curr...

5 years ago
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RE: Design Transfer and Challenges

I think that the biggest issue in design transfer surrounds the timing and coordination of the device design and manufacturing phases. Given the finan...

5 years ago
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RE: Important Part of DDP

While I believe that all components of the DDP are important to medical device development, I would the scope statement to be among the most crucial t...

5 years ago
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RE: Consequences Of Insufficient Design Controls

I think some major issues that arise from the insufficient use of design controls ultimately surround the increased likelihood of failures being reali...

5 years ago
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RE: Placebo-controlled trials: Are they ethical? Are they necessary ?

I believe that placebo-controlled trials are both necessary, as well as ethical, given that the subject is not put at serious risk by not receiving tr...

5 years ago
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RE: Double Blind Vs Single blind Study

I think the main benefit of double versus single-blind studies is to further reduce the introduction of both conscious and unconscious bias. Given tha...

5 years ago
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RE: Discussion Topic: Having a "clinical background"

I would argue that it is important for all personnel involved in clinical research to have at least some clinical background. While I would not expect...

5 years ago
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RE: Corporate Veil

Some circumstances where a court may deem piercing the corporate veil necessary include cases where the separation between the business and owner is n...

5 years ago
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RE: Discussion Topic: Mission and Vision statements

A vision statement communicates the purpose and values of a company by preparing a statement that broadly describes a goal the company wishes to accom...

5 years ago
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