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CE – MDR
ISO 13485
FDA – 21 CFR Part 820
Setup Software QMS
ISO 27001
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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
Services
HOW DO I
Pass an Audit ?
Preparatory internal audit
ISO 13845 audit
ISO 27001 audit
Notified Body
HOW DO I
Strategize Regulation ?
FDA Approval
CE Marking
CE Mark-IVDR
CFDA (NMPA)
HOW DO I
Setup a
Quality System ?
QMS for Medical Device
CE – MDR
ISO 13485
FDA – 21 CFR Part 820
HOW DO I
Setup Software QMS ?
ISO 27001
IEC 62304
HIPAA
HOW DO I
Overcome Hurdles ?
PRRC
Sterilization Validation
Integrate QA & Development
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