ISO 14971-compliant risk management software
Risk management is vital to build safe medical software, but error-prone manual processes leave gaps in the traceability and documentation of risks.
Managing risks effectively can be a daunting task with the constant need to ensure comprehensive documentation, adhere to regulatory standards, and track risk controls. Without a robust system in place, teams struggle with incomplete documentation, overlooked risks, and unverified controls, leading to potential compliance issues and product release delays.
Control and document every risk automatically
Ensure comprehensive risk control
Guarantee complete documentation of all risks and controls compliant with ISO 14971 and prevent product releases with unverified tests of risk controls (IEC 62304).
- Automatically document risks and see unverified risk controls before product release
- Easily review all risks and instantly see the associated risk controls to ensure that no gaps exist
Reduce compliance risk
Product releases are gated by verification and validation tests of risk controls (IEC 62304).
- Gate product releases until all risks are documented, tested, and approved
- Ensure that all necessary risk controls are in place before the product reaches the market
Save time on traceability
Save time by easily navigating across all traced items in any system with a comprehensive traceability matrix.
- Link every risk to its corresponding controls, requirements, and specifications through automated traceability
- Navigate and manage complex risk relationships with ease through an always up-to-date trace matrix
Ensure QMS compliance
Ensures SOPs are followed in any connected system in the correct order.
- Embed Standard Operating Procedures (SOPs) into all connected tools (like Jira and GitHub) so you maintain compliance across all systems
- Ensure that every risk is managed and documented according to industry standards with built-in guardrails
Recapture time to focus on high-risk items
By focusing on high-risk items, you can allocate resources more effectively and ensure that all significant risks are properly controlled.
- Automate low value, time intensive activities to make time for critical activities
- Easily identify and manage the most critical risks with robust filtering capabilities
Give risks and risk controls equivalent priority
- Focus your energy on the most important risks and risk controls by quickly seeing critical risks
- Eliminate unnecessary work by ensuring that development efforts are focused on only those Risk Controls that mitigate the risk identified
- Ensure that Risk Controls adequately address Risks and are properly traced
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