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...

8 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...

8 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...

8 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...

8 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...

8 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...

8 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...

8 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...

8 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 ...

8 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 ...

8 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 ...

8 years ago