DS DS/EN ISO 13485/AC Medical devices - Quality management systems - Requirements for regulatory purposes
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DS DS/EN ISO 13485/AC Document Information:
Title
Medical devices - Quality management systems - Requirements for regulatory purposes
Medicinsk udstyr - Kvalitetsledelsessystemer - Systemkrav til lovmæssige formål
Dansk Standard
Publication Date:
Sep 30, 2009
Scope:
This standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
Keywords:
- AFTER-SALES SERVICES
- APPLICATIONS
- CONSUMER-SUPPLIER RELATIONS
- DEFINITION
- DEFINITIONS
- DELIVERY
- DELIVERY CONDITIONS
- DESIGN
- DEVELOPMENTS
- ELECTRICAL ENGINEERING
- ERECTING (CONSTRUCTION OPERATION)
- INDUSTRIES
- INSPECTION
- INSTALLATION
- INSTALLATIONS
- INSTRUMENTS
- MEDICAL DEVICES
- MEDICAL EQUIPMENT
- MEDICAL INSTRUMENTS
- MEDICAL PRODUCTS
- MEDICAL SCIENCES
- PRODUCTION
- QUALITY
- QUALITY ASSESSMENT SYSTEMS
- QUALITY ASSURANCE
- QUALITY ASSURANCE SYSTEMS
- QUALITY AUDITING
- QUALITY REQUIREMENTS
- SPECIFICATION
- SPECIFICATION (APPROVAL)
- USE
- VERIFICATION
- SPECIFICATIONS
- CO
- AFTER-SALE SERVICES
- MEDICINE
- QUALITY AUDIT
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