Forum

Khemraj Singh
@ks282
Active Member
Joined: Nov 6, 2016
Topics: 1 / Replies: 11
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RE: Consultants NDAs and CDAs

I believe something like this would definitely violate your NDA or CDA. IMO your manager made a great decision. Just having the wrong logo is enough f...

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

I really enjoyed this course. As a student of BME, I find classes in this field do not translate itself to industry all that well. Classes seem more g...

9 years ago
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RE: Collaboration projects

For collaboration projects, I would consider a Product Organizational Structure. This structure has managers reporting to the head of the company by p...

9 years ago
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RE: Forming a Project Team

Firstly, individuals need to be selected that are the best fit for roles within the scope of the project. Individuals who possess the knowledge and ha...

9 years ago
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RE: Discussion Topic: Your organizational type

I work in a matrix organization as a Manufacturing Engineer. I love this organizational style because information travels relatively quickly. Just las...

9 years ago
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RE: Expense of Regulations

Regulation and standards should be abided by regardless of cost. Calibrations/maintenance are costly, but must be done. Safety inspections - also cost...

9 years ago
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RE: The change from ALARP to AFAP

AFAP is deemed acceptable when death or serious deterioration of health is unlikely. ALARP is not acceptable with regard to economic consideration. AL...

9 years ago
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RE: Risk Management Mistakes

From personal experience, I know that the most difficulty in risk management is the need to state a reason for the result. Filling out the risk manage...

9 years ago
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RE: Design Controls for Legacy Combination Products

Legacy devices can be existing devices, modified hardware, and modified software. Legacy medical devices should conform to IEC 62366, a standard that ...

10 years ago
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RE: Important Part of DDP

It's very difficult to select one part of the DPP over the others. If I were to select one I would have to say scope management plan. This determines ...

10 years ago
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RE: Consequences Of Insufficient Design Controls

In design control, there are "checks" to verify that everything (mostly) is accounted for. Companies must question whether the design outputs conform ...

10 years ago