Statements (45)
| Predicate | Object |
|---|---|
| gptkbp:instance_of |
gptkb:standard
|
| gptkbp:bfsLayer |
5
|
| gptkbp:bfsParent |
gptkb:ISO_14971
|
| gptkbp:aims_to |
Ensure safety of medical devices
|
| gptkbp:applies_to |
Medical devices
In vitro diagnostic devices Software as a medical device |
| gptkbp:complement |
ISO 14971-2
|
| gptkbp:emphasizes |
Continuous improvement
|
| gptkbp:focuses_on |
Evaluating risks
Monitoring risks Controlling risks Estimating risks Identifying hazards |
| https://www.w3.org/2000/01/rdf-schema#label |
ISO 14971-1
|
| gptkbp:includes |
Risk analysis
Risk control Risk evaluation Post-market surveillance |
| gptkbp:is_adopted_by |
gptkb:legislation
gptkb:Health_Canada gptkb:PMDA_(Pharmaceuticals_and_Medical_Devices_Agency)_Japan gptkb:TGA_(Therapeutic_Goods_Administration)_Australia ANVISA (Agência Nacional de Vigilância Sanitária) Brazil MHRA (Medicines and Healthcare products Regulatory Agency) UK |
| gptkbp:is_cited_in |
Regulatory bodies
|
| gptkbp:is_designed_to |
Manufacturers of medical devices
|
| gptkbp:is_part_of |
Medical device lifecycle
|
| gptkbp:is_referenced_in |
gptkb:IVDR_(In_Vitro_Diagnostic_Regulation)_EU_2017/746
gptkb:MDR_(Medical_Device_Regulation)_EU_2017/745 FDA guidelines |
| gptkbp:is_reviewed_by |
ISO technical committees
|
| gptkbp:is_standardized_by |
Risk management standard
|
| gptkbp:objective |
Provides a framework for risk management for medical devices
|
| gptkbp:part_of |
gptkb:ISO_14971
|
| gptkbp:provides_information_on |
Risk management process
|
| gptkbp:published_by |
gptkb:organization
|
| gptkbp:published_year |
gptkb:2019
|
| gptkbp:related_to |
Risk management
|
| gptkbp:replaced_by |
gptkb:ISO_14971:2007
|
| gptkbp:requires |
Documentation of risk management activities
|
| gptkbp:supports |
Quality management systems
|
| gptkbp:title |
Medical devices -Application of risk management to medical devices -Part 1: Application of risk management to medical devices
|
| gptkbp:updates |
ISO 14971-1:2021
|
| gptkbp:used_in |
Regulatory compliance
|