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Technical Standard
DIN EN ISO 13485
AM specific?
No
Status:
published
Medical devices – Quality management systems – Requirements for regulatory purposes
Publisher
DIN
EN
ISO
Scope
feedstock
material
production site
Technology
not technology-specific
Material
not material specific
Use of standard
certification
Branch
Medical Devices
Related Standards
ISO 14971
Medical devices — Application of risk management to medical devices
Technology
not technology-specific
Material
not material specific
Use of Standart
guideline
,
qualification
Branch
Medical
,
Medical Devices
view details
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