|
gptkbp:instance_of
|
gptkb:standard
|
|
gptkbp:amended_by
|
gptkb:2016
|
|
gptkbp:complement
|
gptkb:ISO_14971
|
|
gptkbp:first_published
|
gptkb:2003
|
|
https://www.w3.org/2000/01/rdf-schema#label
|
ISO 13485
|
|
gptkbp:is_adopted_by
|
medical device manufacturers
startups in healthcare
software development in medical devices
|
|
gptkbp:is_aligned_with
|
customer satisfaction goals
|
|
gptkbp:is_applicable_to
|
organizations involved in medical device design
|
|
gptkbp:is_associated_with
|
risk management practices
|
|
gptkbp:is_audited_during
|
regulatory inspections
|
|
gptkbp:is_challenged_by
|
changing regulations
|
|
gptkbp:is_critical_for
|
patient safety
product safety
product recalls
|
|
gptkbp:is_designed_for
|
consistent design and manufacturing processes
|
|
gptkbp:is_documented_in
|
standard operating procedures
quality manuals
|
|
gptkbp:is_enhanced_by
|
technology advancements
employee training
|
|
gptkbp:is_essential_for
|
market access
|
|
gptkbp:is_evaluated_by
|
performance metrics
peer reviews
internal audits
third-party auditors
|
|
gptkbp:is_facilitated_by
|
management commitment
|
|
gptkbp:is_focused_on
|
regulatory requirements
|
|
gptkbp:is_global_standard_for
|
medical device quality management
|
|
gptkbp:is_implemented_in
|
quality assurance processes
|
|
gptkbp:is_influenced_by
|
global health trends
|
|
gptkbp:is_informed_by
|
customer feedback
|
|
gptkbp:is_integrated_with
|
gptkb:supply_chain_management
other management systems
|
|
gptkbp:is_linked_to
|
product lifecycle management
sustainability practices
|
|
gptkbp:is_often_used_in
|
healthcare organizations
|
|
gptkbp:is_part_of
|
ISO 13400 series
|
|
gptkbp:is_promoted_by
|
trade associations
|
|
gptkbp:is_promoted_through
|
conferences and seminars
|
|
gptkbp:is_recognized_by
|
gptkb:FDA
|
|
gptkbp:is_referenced_in
|
regulatory submissions
|
|
gptkbp:is_related_to
|
gptkb:medical_devices
|
|
gptkbp:is_reviewed_by
|
industry experts
|
|
gptkbp:is_similar_to
|
gptkb:ISO_9001
|
|
gptkbp:is_subject_to
|
continuous improvement
market surveillance
|
|
gptkbp:is_supported_by
|
training programs
consulting services
regulatory bodies
|
|
gptkbp:is_updated_by
|
every few years
|
|
gptkbp:is_used_in
|
quality management systems
|
|
gptkbp:is_utilized_for
|
supplier management
|
|
gptkbp:is_utilized_in
|
clinical trials
|
|
gptkbp:published_by
|
gptkb:International_Organization_for_Standardization
|
|
gptkbp:requires
|
ISO certification
CE marking in Europe
|
|
gptkbp:bfsParent
|
gptkb:ISO
gptkb:International_Organization_for_Standardization
|
|
gptkbp:bfsLayer
|
4
|