SoftComply Risk Manager PLUS is an add-on for Jira to manage, track and report safety-critical product risks using Hazard Analysis and/or FME(C)A.
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SoftComply Risk Manager Plus is fully customizable and
integrated with Atlassian JIRA.
Features
CUSTOMIZABLE
SoftComply Risk Manager Plus is a Risk Analysis add-on for Jira that is fully customizable to any risk management method or approach including Hazard Analysis and FME(C)A. Supports FME(C)A with or without Detectability parameter & RPN (Risk Prioritization Numbers).
TRACEABILITY
SoftComply Risk Manager Plus builds full traceability of risks through links between risks, their mitigation actions, test cases and other related risks for audit trails.
REPORTING
Automated generation of pre-filled and tailorable ISO14971-compliant Risk Reports (Risk Management Plan and Risk Management Report) including the visualization of risks of your choise, i.e. either in Initial and Residual Risk Matrices or in RPN (Risk Prioritization Numbers).
Benefits
SUPPORTS FDA AND CE-MARKING
SoftComply Risk Manager is based on ISO 14971 and IEC 62304 comprehensively focusing on the EU and USA markets .
SAFETY CRITICAL
SoftComply Risk Manager is a must-have Jira add-on for any safety-critical system developer where compliant risk management is a regulatory requirement, e.g. in medical device or automotive industries.
INTEGRATION
SoftComply Risk Manager Plus is fully integrated to Atlassian Jira, with transparent pricing and full support from SoftComply
How it works
The majority of our clients are from the USA, the UK, and the rest of the Europe & they include startups as well as Fortune 500 companies.
900$ Per year
Safety critical
Compliant Risk Management for Safety Critical Industry!
Supports traceability
Each risk can be linked to requirements, mitigation actions, verification actions and other risks!
Compliant reporting
Reports are generated automatically
from your risk matrices!