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DS/EN 1441 - MEDICAL DEVICES - RISK ANALYSIS Organization: DS
Date: 1999-12-07
Description: This standard specifies a procedure for the manufacturer to investigate, using available information, the safety of a medical device, including in vitro diagnostic devices or accessories, by identifying hazards and estimating the risks associated with the device.
DS/CEN/CR 14060 - MEDICAL DEVICE TRACEABILITY Organization: DS
Date: 2001-02-21
Description: This technical report provides recommendations for procedures that should be followed to establish, as far as possible, a traceability route for medical devices which have been placed on the market.
HHS - 21 CFR PART 810 - MEDICAL DEVICE RECALL AUTHORITY Organization: HHS
Date: 2014-04-01
Description: Part 810 describes the procedures that the Food and Drug Administration will follow in exercising its medical device recall authority under section 518(e) of the Federal Food, Drug, and Cosmetic Act.
HHS - 21 CFR PART 810 - MEDICAL DEVICE RECALL AUTHORITY Organization: HHS
Date: 2017-04-01
Description: Part 810 describes the procedures that the Food and Drug Administration will follow in exercising its medical device recall authority under section 518(e) of the Federal Food, Drug, and Cosmetic Act.
HHS - 21 CFR PART 810 - MEDICAL DEVICE RECALL AUTHORITY Organization: HHS
Date: 2015-04-01
Description: Part 810 describes the procedures that the Food and Drug Administration will follow in exercising its medical device recall authority under section 518(e) of the Federal Food, Drug, and Cosmetic Act.
HHS - 21 CFR PART 810 - MEDICAL DEVICE RECALL AUTHORITY Organization: HHS
Date: 2016-04-01
Description: Part 810 describes the procedures that the Food and Drug Administration will follow in exercising its medical device recall authority under section 518(e) of the Federal Food, Drug, and Cosmetic Act.
SAE J3020 - MEDICAL DEVICE SHOT PEENING Organization: SAE
Date: 2014-05-01
Description: This SAE Standard and its supplementary detail specifications cover the engineering requirements for the controlled shot peening of a medical device where shot peening is required for enhancement of a material's mechanical properties through the intentional creation of compressive residual stress.
CRC - E2122 - MEDICAL DEVICES AND SYSTEMS Organization: CRC
Date: 2006-04-19
Description: Engineers must be prepared to develop technologies that are more than incremental improvements over existing devices and systems. Medical Devices and Systems illuminates a path to achieving remarkable breakthroughs.
CRC - KE21198 - PREVENTING MEDICAL DEVICE RECALLS Organization: CRC
Date: 2014-07-25
Description: A critical and often overlooked aspect of preventing medical device recalls is the ability to implement systems thinking.
HHS - 21 CFR PART 803 - MEDICAL DEVICE REPORTING Organization: HHS
Date: 2017-04-01
Description: (a) This part establishes the requirements for medical device reporting for device user facilities, manufacturers, importers, and distributors.
DOL - 21 CFR PART 803 - MEDICAL DEVICE REPORTING Organization: DOL
Date: 2016-04-01
Description: (a) This part establishes the requirements for medical device reporting for device user facilities, manufacturers, importers, and distributors.
DS/EN ISO 14971 - MEDICAL DEVICES – APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES Organization: DS
Date: 2012-12-21
Description: ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
JSA - JIS T 14971 - MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES Organization: JSA
Date: 2012-03-01
Description: This Standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
CEN - EN ISO 14971 - MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES Organization: CEN
Date: 2012-07-01
Description: This International Standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
DSF/EN 62366/FPRA1 - MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES Organization: DS
Description: This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to SAFETY of a MEDICAL DEVICE. This USABILITY ENGINEERING PROCESS assesses and mitigates RISKS caused by USABILITY problems associated with CORRECT USE and USE ERRORS.
AAMI 14971 - MEDICAL DEVICES—APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES Organization: AAMI
Date: 2007-01-01
Description: This International Standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
SNV - SN EN ISO 14971 - MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES Organization: SNV
Date: 2012-09-01
Description: This International Standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
ISO 14971 - MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES - SECOND EDITION; CORRECTED VERSION 10/01/2007 Organization: ISO
Date: 2007-03-01
Description: This International Standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
DSF/EN 62366/FPRA1 - MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES Organization: DS
Description: Specifies a process for a manufacturer to analyse, specify, design, verify and validate usability, as it relates to safety of a medical device. This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, i.e. normal use.
DS/EN 62366 - MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES Organization: DS
Date: 2008-02-19
Description: This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to SAFETY of a MEDICAL DEVICE. This USABILITY ENGINEERING PROCESS assesses and mitigates RISKS caused by USABILITY problems associated with CORRECT USE and USE ERRORS.

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