1. In the US, direct and indirect sales representatives are constrained in how they sell a device by the regulatory clearance/approval granted by the FDA
True
Or
False
2. The following are true statements about quality systems except:
a. The FDA’s quality systems regulations are highly prescriptive and subject to limited interpretation
b. Companies can implement their quality systems in a progressive manner, focusing on those elements most relevant to their stage of growth.
c. Senior executives have ultimate legal responsibility for the effectiveness of the company’s quality system.
d. Quality systems can be a source of competitive advantage for a company.
1. In the US, direct and indirect sales representatives are constrained in how they sell a device by the regulatory clearance/approval granted by the FDA
True
Or
False
2. The following are true statements about quality systems except:
a. The FDA’s quality systems regulations are highly prescriptive and subject to limited interpretation
b. Companies can implement their quality systems in a progressive manner, focusing on those elements most relevant to their stage of growth.
c. Senior executives have ultimate legal responsibility for the effectiveness of the company’s quality system.
d. Quality systems can be a source of competitive advantage for a company.
Related textbook solutions
Related questions
All of the following statements are TRUE regarding the results of a scientific study EXCEPT:
| The results are the direct outcome of the experiments. |
| The results may be quantitative or qualitative. |
| The results are the interpretations of what the data means. |
| Each experimental study can produce many results. |
1. What advantages do regulatory systems provide to bacteria?
| Regulatory systems allow the necessary mutation of bacterial genes to enable them to adapt in different environments. | |
| Regulatory systems enable bacteria to function normally in the absence of nutrient medium. Regulatory systems enable faster rates of transcription when bacteria enter a new environment. |
2. Why are genes related to common functions found together in operons?
| Having genes with related functions together in operons provides for inhibition of undesirable processes. | |||||
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