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Evaluation of the R&D process:
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Review the R&D department and key technical
people
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Product technical analysis:
a. Highlight technology or special know how
that is unique in the production of this
product
b. Implement critical analysis of
technologies and parts
c. Carry out an analysis of the key critical
subcontractors
d. Assess product maturity in terms of
production readiness
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Regulatory Subjects:
a. Determine that the product complies with
safety regulations (electrical safety,
radiation safety, etc.)
b. Establish if there are technical barriers
to overcome in order to get a CE mark, or
FDA approval
c. Set up an R&D work plan
d. Create a regulatory R&D workflow (Design
reviews, Documentation)
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R&D recommendations
a. Make recommendations regarding the
product's technical definitions
b. Identify the product's main technical
problems and provide alternative
solutions.
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Product finalization
Determine what still has
to be done to proceed to mass production
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