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ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.
The sub-clause 4.2.3 of ISO 13485:2016 requires a manufacturer of medical device to establish a Technical file, similar to a device master record. The EU medical device regulation requires a manufacturer of a medical device to maintain a Technical documentation.
ISO 13485:2016 is applicable to all providers and manufacturers of medical devices, components, contract services and distributors of medical devices. The standard is the basis for regulatory compliance in local markets, and most export markets.
The sub-clause 7.3.10 of ISO 13485:2016 requires a manufacturer of a medical device to maintain (and control) a design and development file for a medical device to document the design history of a medical device. This file shall also contain records for changes in design and development (per device type or family).
ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes ISO/IEC 13490 Information technology – Volume and file structure of read-only and write-once compact disk media for information interchange
ISO 9000:2005 provides information on the fundamentals and vocabulary used in quality management systems. ISO 9004:2009 provides guidance on a quality management approach for the sustained success of an organization. Neither of these standards can be used for certification purposes as they provide guidance, not requirements.
ISO 14405-1:2016 Part 1: Linear sizes; ISO 14405-2:2011 Part 2: Dimensions other than linear sizes; ISO 14405-3:2016 Part 3: Angular sizes; ISO 14406:2010 Geometrical product specifications (GPS) - Extraction; ISO 14408:2016 Tracheal tubes designed for laser surgery – Requirements for marking and accompanying information
ISO 11418-1:2016 Part 1: Drop-dispensing glass bottles; ISO 11418-2:2016 Part 2: Screw-neck glass bottles for syrups; ISO 11418-3:2016 Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms; ISO 11418-5:2015 Part 5: Dropper assemblies; ISO 11418-7:2016 Part 7: Screw-neck vials made of glass tubing for liquid dosage forms
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