ISO/IEC 33020:2015
|
Information technology Process assessment Process measurement framework for assessment of process capability |
DIN EN ISO 13485:2016-08
|
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) |
ISO/IEC 15504-4:2004
|
Information technology Process assessment Part 4: Guidance on use for process improvement and process capability determination |
IEC TR 80002-3:2014
|
Medical device software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304) |
IEC 60601-1:2005+AMD1:2012 CSV
|
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
ISO/IEC 33001:2015
|
Information technology Process assessment Concepts and terminology |
DIN EN 62366 : 2016
|
MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007 + A1:2014) |
ISO 13485:2016
|
Medical devices Quality management systems Requirements for regulatory purposes |
VDE 0750-101 : 2016
|
MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES |
DIN EN ISO 14971:2013-04
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007) |
EN 62304:2006/A1:2015
|
MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES (IEC 62304:2006/A1:2015) |
ISO/IEC 33003:2015
|
Information technology Process assessment Requirements for process measurement frameworks |
IEC 62366:2007+AMD1:2014 CSV
|
Medical devices - Application of usability engineering to medical devices |
ISO/IEC 15504-2:2003
|
Information technology Process assessment Part 2: Performing an assessment |
VDE 0750-241 : 2016
|
MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007 + A1:2014) |
VDI 1000:2017-02
|
VDI Standardisation Work - Principles and procedures |
IEC 62304:2006+AMD1:2015 CSV
|
Medical device software - Software life cycle processes |
ISO/IEC 33002:2015
|
Information technology Process assessment Requirements for performing process assessment |
ISO/IEC 12207:2008
|
Systems and software engineering Software life cycle processes |
EN 62366 : 2008 AMD 1 2015
|
MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014) |
EN ISO 14971:2012
|
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
DIN EN 62304 : 2016
|
MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES |
ISO 14971:2007
|
Medical devices Application of risk management to medical devices |
ISO/IEC 15504-1:2004
|
Information technology Process assessment Part 1: Concepts and vocabulary |
VDE 0750-1 : 2013
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005 + COR.:2006 + COR.:2007 + A1:2012) |
ISO/IEC 33004:2015
|
Information technology Process assessment Requirements for process reference, process assessment and maturity models |