Every company depends on others to survive. From your cloud provider to your payroll processor, your business is connected to a web of vendors. But here’s the reality: over 60% of data breaches origi...
Most companies have informal risk discussions in meetings. You know the type – “What happens if our lead developer leaves?” or “What if this big deal doesn’t close?”. These conversations usually end ...
Project managers know that uncertainty is the enemy of successful delivery. You’ve got potential risks lurking around every corner, assumptions that might prove wrong, current issues demanding attent...
GRC (Governance, Risk and Compliance) isn’t just corporate bureaucracy – it’s your company’s shield against costly surprises. Too many organizations scramble during audits, struggle with scattered ri...
Risk reporting isn’t just another checkbox on your compliance list. It’s the backbone of effective risk management that keeps your team informed, your management happy, and your auditors satisfied. W...
Hazard analysis is the must-have risk management approach in medical device industry. While many companies stick with single probability values in their hazard analysis, ISO 14971 suggests b...
Medical device risk management isn’t just another regulatory checkbox. It’s the foundation that proves your device is safe for patients and users. When auditors come knocking, they’ll scrutinize your...
In the medical device industry, risk management is not just a regulatory requirement. It is a fundamental practice to ensure the safety, effectiveness and quality of devices that directly impact pati...
The Role of Cybersecurity in Medical Device Safety The Global medical device market is a $800 billion business that is rapidly growing, especially in the area of software as a medical device (SaMD)...
Integrating risk management into the Software Development Lifecycle (SDLC) of a product is crucial to its success. It enhances the safety, security and reliability of your software product. When you ...
What is CVSS and when to use it? The Common Vulnerability Scoring System (CVSS) is a standardized framework for rating the severity of security vulnerabilities. The CVSS was developed an...
If you’re considering using Excel for your Risk Register, this video explains why that might not be the best choice. Instead, we introduce a more effective alternative using Jira and dedicated risk...
What is a Risk Register and Where to Build It? Risk Management is an essential governance practice for enterprise, product, portfolio, information security and project management. Proactive ri...
A risk manager continuously identifies, assesses, and mitigates potential risks that could impact an organization’s objectives. They develop strategies to minimize threats, ensure compliance...
When it comes to managing risks in project management, using Jira for risk management can significantly improve your team's productivity and effectiveness. Risk management involves identifying, ass...
Project risk management is crucial for project success, and especially important to keep critical risks under check in case of (inevitable) changes. The hidden complexities of a project is the main r...
In the Medical Device industry software components, whether standalone or as part of a physical device, must follow the same rules as any other component, i.e. ISO 14971 “Medical devic...
In the Medical Device industry software components, whether standalone or as part of a physical device, must follow the same rules as any other component, i.e. ISO 14971 “Medical devic...
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