Statements (65)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:International_Standard
|
| gptkbp:appliesTo |
medical devices
|
| gptkbp:canLeadTo |
market access
|
| gptkbp:developedBy |
gptkb:International_Organization_for_Standardization
|
| gptkbp:ensures |
regulatory requirements
|
| gptkbp:facilitates |
product recalls
|
| gptkbp:focusesOn |
quality management systems
|
| gptkbp:hasMember |
risk management
|
| gptkbp:hasVolunteers |
for many organizations
|
| https://www.w3.org/2000/01/rdf-schema#label |
ISO 13485 certification
|
| gptkbp:isAccessibleBy |
design and development
|
| gptkbp:isAssociatedWith |
regulatory inspections
|
| gptkbp:isAttendedBy |
certification bodies
healthcare_organizations |
| gptkbp:isAvailableIn |
various countries
|
| gptkbp:isBeneficialFor |
small and medium enterprises
patient outcomes |
| gptkbp:isCriticizedFor |
product lifecycle management
regulatory compliance audits |
| gptkbp:isEquippedWith |
certain markets
CE_marking_in_Europe |
| gptkbp:isEvaluatedBy |
performance metrics
internal audits third-party auditors |
| gptkbp:isImportantFor |
supply chain management
regulatory submissions |
| gptkbp:isInfluencedBy |
global standards
|
| gptkbp:isIntegratedWith |
other management systems
|
| gptkbp:isLinkedTo |
patient safety
customer satisfaction sustainability practices |
| gptkbp:isPartOf |
corporate governance
risk management process quality assurance framework product registration process regulatory compliance strategy ISO_13485_family_of_standards |
| gptkbp:isPromotedBy |
industry associations
|
| gptkbp:isPromotedThrough |
conferences and workshops
|
| gptkbp:isRecognizedBy |
regulatory authorities
|
| gptkbp:isRecognizedFor |
international markets
a mark of quality |
| gptkbp:isRelatedTo |
gptkb:ISO_9001
ISO 14971 |
| gptkbp:isSubjectTo |
changes in technology
recertification every three years |
| gptkbp:isSupportedBy |
training programs
|
| gptkbp:isUpdatedBy |
to reflect changes in regulations
|
| gptkbp:isUsedBy |
improve operational efficiency
manufacturers of medical devices enhance brand reputation document quality objectives ensure traceability of products manage supplier quality track_nonconformities |
| gptkbp:isUsedIn |
clinical trials
|
| gptkbp:isUtilizedFor |
quality assurance
product development clinical evaluation product innovation |
| gptkbp:keyIssues |
business success in medical device industry
|
| gptkbp:promotes |
continuous improvement
|
| gptkbp:requires |
quality management system
quality management processes |
| gptkbp:supports |
product safety
|