DIN EN ISO 13485:2021 Edition

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Medical devices – Quality management systems – Requirements for regulatory purposes

Published By	Publication Date	Number of Pages
DIN	2021-12	73

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Categories: 03.100.70 - Management systems, 11.040.01 - Medical equipment in general, DIN

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Description

This International 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 and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e. g. technical support). This International Standard can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations. Amendment 11 replaces the European Annexes Z which disclose the relationship between clauses of the standard and the EU Directives by the European Annexes Z which disclose the relationship between clauses of the standard and the EU Regulations on medical devices and in vitro diagnostics respectively.

Additional information

Published Code	DIN
Published By	Deutsches Institut für Normung
Publication Date	2021-12
Pages Count	73
Language	English
Descriptors	Acceptance specification, After-sales services, Applications, Auditing, CE marking, Conduits, Consumer-supplier relations, Corrections, Customers, Data, Definitions, Delivery, Delivery conditions, Design, Detail specification, Developments, Documentation, Editing, Electrical engineering, Erecting (construction operation), Establishment, Evaluations, Handbooks, Handling, Industries, Inspection, Installation, Installations, Instruments, International standards, Maintenance, Management systems, Medical devices, Medical equipment, Medical instruments, Medical products, Medical sciences, Methods, Organization, Packages, Planning, Preservation, Preventive actions, Process, Process management, Procurements, Product design, Product planning, Production, Products, Quality, Quality assessment systems, Quality assurance, Quality assurance systems, Quality auditing, Quality control, Quality improvement, Quality management, Quality requirements, Responsibility, Return current, Sellers, Services, Shipping, Specification, Specification (approval), Standards, Steering gear, Storage, Surveillance (approval), Testing, Training, Treatment, Use, Verification, Cords, Supplying, Bearings, Processes, Procedures, Electric cables, Implementation, Manuals, Pipelines, Presentations
File Size	2.5 MB
ICS Codes	03.100.70 - Management systems 11.040.01 - Medical equipment in general

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DIN EN ISO 13485:2021 Edition

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