hi every one
My question is what is the output of risk management output in the ISO 13485 :7.3.2.
7.3.2 Design and development inputs
Inputs relating to product requirements shall be determined and records maintained (see 4.2.4). These inputs
shall include
a) functional, performance and safety requirements, according to the intended use,
b) applicable statutory and regulatory requirements,
c) where applicable, information derived from previous similar designs,
d) other requirements essential for design and development, and
e) output(s) of risk management (see 7.1).
These inputs shall be reviewed for adequacy and approved.
Requirements shall be complete, unambiguous and not in conflict with each other.
My question is what is the output of risk management output in the ISO 13485 :7.3.2.
7.3.2 Design and development inputs
Inputs relating to product requirements shall be determined and records maintained (see 4.2.4). These inputs
shall include
a) functional, performance and safety requirements, according to the intended use,
b) applicable statutory and regulatory requirements,
c) where applicable, information derived from previous similar designs,
d) other requirements essential for design and development, and
e) output(s) of risk management (see 7.1).
These inputs shall be reviewed for adequacy and approved.
Requirements shall be complete, unambiguous and not in conflict with each other.
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