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  2. ISO 13485 - Wikipedia

    en.wikipedia.org/wiki/ISO_13485

    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.

  3. Device Master Record - Wikipedia

    en.wikipedia.org/wiki/Device_Master_Record

    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.

  4. Design history file - Wikipedia

    en.wikipedia.org/wiki/Design_history_file

    A design history file is a compilation of documentation that describes the design history of a finished medical device.The design history file, or DHF, is part of regulation introduced in 1990 when the U.S. Congress passed the Safe Medical Devices Act, which established new standards for medical devices that can cause or contribute to the death, serious illness, or injury of a patient.

  5. Design controls - Wikipedia

    en.wikipedia.org/wiki/Design_controls

    ISO 13485 is a voluntary standard that contains section 7.3 Design and Development recommending which procedures should be put in place by manufacturers in order to have a quality system that will comply with MDD 93/42/EEC and the MDR.

  6. Verification and validation - Wikipedia

    en.wikipedia.org/wiki/Verification_and_validation

    Verification is intended to check that a product, service, or system meets a set of design specifications. [6] [7] In the development phase, verification procedures involve performing special tests to model or simulate a portion, or the entirety, of a product, service, or system, then performing a review or analysis of the modeling results.

  7. Quality management - Wikipedia

    en.wikipedia.org/wiki/Quality_management

    ISO 13485 specifies Quality Management System requirements for organizations involved in the design and manufacture of medical devices in order to demonstrate the ability to meet relevant regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and ...

  8. List of ISO standards 12000–13999 - Wikipedia

    en.wikipedia.org/wiki/List_of_ISO_standards_12000...

    ISO 13482:2014 Robots and robotic devices – Safety requirements for personal care robots; 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

  9. List of ISO standards 14000–15999 - Wikipedia

    en.wikipedia.org/wiki/List_of_ISO_standards_14000...

    ISO 15883-1:2006 specifies general performance requirements for washer-disinfectors (WD) and their accessories that are intended to be used for cleaning and disinfection of re-usable medical devices and other articles used in the context of medical, dental, pharmaceutical and veterinary practice.

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