ISO/CMDCAS/MDD/IVDD
Request for preliminary cost estimation

ISO13485　 ISO9001　　　　 CMDCAS according to ISO13485

QMS Conformity Assesment (Combine with ISO13485 audit)

MDD Annex V　 MDD Annex II.3　 IVDD Annex VII　 IVDD Annex IV

MDD Annex III　 MDD Annex II.4　 IVDD Annex V　 IVDD Annex IV.4

Scope
MDD/IVDD classification
Activity	Design/Development　 Production　 Distribution　 Others
No. of facility in the scope
No. of employee in the scope （ｉｎ each of facility）	( example of more than one facility:80,150,200)

Certified by other notified body （ Roll over） 　　Standard： Notified Body：

Implemented but not certified

Not established

Technical document file is completed
Under preparation of technical document file
Not started yet

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