Do device hazard analysis

General :
Version:	1.0

Project :
Author:	Wolfgang Kern
Created:	14.03.2014 14:44:28
Modified:	16.09.2019 15:04:32

Diagram Elements :

SW Design specification

SW Requirements specification

Determine residual risk to be published

RCB Risk Control Board

Determine if medical benefit is grater than residual risk

Determine if all defined measures were implented and verified

Assure that all known hazards were assessed

CAPA Corrective and preventive action

Nonconformity of processes

Complaint report

Nonconformity of components

Design Specifications (DS)

System Requirement / Use Specifications (SysRS/US)

Product Requirement Specifications (PRS)

Determine related effects and severity

Potential hazard assessed

Justify medical benefit / risk ratio for specific hazard

New risks?

Evaluate new risks induced by DHA mitigation

Risk acceptable?

Determine risk acceptability

Determine risk after mitigation

Determine risk before mitigation

Determine risk mitigations

RM Representative

Device Hazard Analysis (DHA)

Analyze potential hazards and probability

New potential hazard