A manufacturer won a contract to build medical equipment, which represents an extension of its main computer assembling business. Considering the standards between each line of business, which of…

The correct answer is C. Quality. Medical equipment is subject to strict regulatory and quality standards (such as FDA regulations, ISO 13485, and other medical device directives) that are far more rigorous than those applied to commercial computer assembly. Since the company is entering an entirely new…

Project management concepts

Question

A manufacturer won a contract to build medical equipment, which represents an extension of its main computer assembling business. Considering the standards between each line of business, which of the following constraints will likely have the MOST impact on the project?

Options

AResources
BDeliverables
CQuality
DEnvironment

How the community answered

(28 responses)

A
11% (3)
B
7% (2)
C
79% (22)
D
4% (1)

Explanation

Medical equipment is subject to strict regulatory and quality standards (such as FDA regulations, ISO 13485, and other medical device directives) that are far more rigorous than those applied to commercial computer assembly. Since the company is entering an entirely new regulatory domain, quality standards will impose the greatest impact on the project - affecting design, testing, documentation, materials, and manufacturing processes. Resources, deliverables, and environment may also be affected, but the root driver of those impacts is the difference in quality requirements between the two lines of business.

Topics

#quality constraints#regulatory standards#project constraints#compliance

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