Hot Potato

Developing true interdependence between clinical teams and business-sustaining functions is a challenge. The learning curve is steep—particularly when navigating the complexities of ISO 14971 and ISO 24971—and failure to properly integrate risk management updates can lead to compliance liabilities.

One of the biggest hurdles organizations face is the lack of a clear leader to drive the transition. While multiple departments contribute to risk management, a designated subject matter expert (SME) is essential to facilitate collaboration, answer questions, and streamline updates.

In the early stages, many organizations turn to consultants to manage the first round of updates. This allows internal teams to learn best practices without disrupting ongoing operations. However, the long-term goal should be to establish a sustainable, internal process where risk management updates become a routine part of business operations.

Building Interdependence Across Teams

Developing true interdependence between clinical teams and business-sustaining functions is easier said than done. The learning curve is steep—particularly when navigating the complexities of ISO 14971 and ISO 24971—and failure to properly integrate risk management updates can lead to compliance liabilities.

To bridge the gap, organizations must designate a risk management subject matter expert who can facilitate cross-functional collaboration and ensure that documentation updates align with regulatory expectations. In the interim, many companies have successfully leveraged consultants to guide their first remediation efforts, ensuring compliance without unnecessary disruptions.

Streamlining the Risk Management Workflow

To ensure accountability and efficiency, organizations should integrate risk management updates into existing compliance processes. One effective approach is to include risk management status updates in Management Review meetings. This allows leadership to:

• Track the timeliness of Risk Management Reports
• Identify changes in risk acceptability, severity, or probability of harm
• Ensure resource allocation for ongoing MDR compliance

Additionally, risk management should not be treated as a series of disconnected documents. Instead, organizations should aim for one consolidated risk analysis document that is continuously updated. This approach mirrors document change order (DCO) processes and ensures greater visibility and consistency across departments.

Key Takeaways

• Risk management and clinical evaluation are interdependent and must be updated regularly.
• No single department “owns” risk management updates—collaboration across Regulatory Affairs, R&D, Quality Engineering, and Quality Systems is essential.
• A dedicated subject matter expert (SME) should lead risk management updates to ensure consistency and compliance.
• Management Review should track risk management updates to ensure accountability and alignment with MDR requirements.
• A single, streamlined risk analysis document helps improve efficiency and reduce compliance risks.

For organizations navigating MDR remediation, having the right processes, leadership, and collaboration in place will make risk management updates a sustainable and manageable part of operations.

For additional guidance, the following procedures and forms are available on QMS Velocity to assist with the risk management remediation process:

Risk Management Remediation Quality Plan – QMS Velocity

Risk Management Workbook-MDR – QMS Velocity

Software Validation, Risk Management Workbook – QMS Velocity