chapter  13
18 Pages

ISO 13485 Requirements/Compliance

Thestandardspecifies,inconjunctionwithISO900I,thequality systemrequirementsforthedesigndevelopment,production,andwhere relevant,installationandservicingofmedicaldevices.Thisstandard,in conjunctionwithISO9001isapplicablewherethereisaneedtoassessa medicaldevicemanufacturer'squality5ystemorwhenaregulatoryrequirement specifiesthatthisstandardwillbeusedforsuchassessment.