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CE – MDR
ISO 13485
FDA – 21 CFR Part 820
Setup Software QMS
ISO 27001
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HIPAA
Overcome Hurdles
Become PRRC
Sterilization Validation
Integrate QA & Development
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How Do I
Pass an audit
Preparatory internal audit
ISO 13485 Audit
ISO 27001 Audit
Notified Body
Strategize regulation
Strategize Regulation
Get FDA Approval
CE Mark – IVDR
Get CE marking
Chinese approval (CFDA)
Setup Quality System
QMS for Medical Device
ISO 13485
FDA – 21 CFR Part 820
CE – MDR
Setup Software QMS
ISO 27001
IEC 62304
HIPAA
Overcome Hurdles
Become PRRC
Sterilization Validation
Integrate QA & Development
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