European Medical Device CE marking under the Medical Device Directive, 93/42/EEC:  Chapters 1 through 6 by Emergo.

US FDA - Chapters 1 through 7 by Emergo

#IEC60601 #ISO 13485 #ISO14971 #MDD #particular60601 #collateral60601 #FDA 510K #FDA PMA #MDD #CEMarking #Class I #ClassIIa #ClassIIb #riskassessment #riskanalysis #qualitymanagementsystem #compliance #medica devicedirective #machinerydirective #REACH #RoHS #lowvoltagedirective #93/42/EEC #QMS