Risk Management

Effective risk management requires a beginning-to-end approach to establishing, supporting and sustaining device safety throughout the product lifecycle. Our quality and engineering professionals have practical experience in applying the current medical device risk management standards to medical devices, pharmaceuticals and combination products.

Overview of Risk Management

Risk Management Program Development

A risk management program starts by having the right procedures in place, with proper linkage and integration into quality management system processes including design control, production and process control, purchasing control (supplier quality management), CAPA, and post-market surveillance (complaint handling and adverse event reporting).

QualityHub’s quality and engineering professionals can:

  • Provide fundamental training on the application of risk management principles.
  • Assist in the development of procedures, work instructions and templates for risk management.
  • Prepare training curriculum and case studies to support implementation of risk management processes across the quality system.
  • Assess risk management documentation for compliance with current standards such as ISO 14971, AAMI TIR32, IEC 60601-1-2, and ICH Q9.
Risk Management File Development & Remediation

The expectations for risk management in regulated life science companies have matured over time. Products developed many years ago may not have the same level of robust risk management documentation that would be applicable in today’s regulatory environment. If it is time to update, remediate or improve your risk management files, QualityHub can provide the expertise and resources to get it done.

If you are looking for assistance with risk management, QualityHub can:

  • Establish the strategy and plans development or remediation of risk management files.
  • Execute the development or update of risk management documentation.
  • Work with engineering teams to perform hazard analysis and risk analysis (FTAs, FMEAs, etc.).
  • Review the outputs of risk assessment activities or remediation efforts to ensure alignment with plans.
  • Mine databases for new hazards and harms identified through post-market surveillance activities.
  • Develop risk management reports.
  • Verify the effectiveness and proper documentation of risk control measures.
Health Hazard Evaluations (HHE)

When an unexpected product problem arises, it is important to quickly assess the risk to users based on current data. Health Hazard Evaluations help leadership teams make timely and appropriate decisions with proper justification for field corrective actions, recalls and notifications to regulatory authorities. HHEs also help to provide input for the update of the risk management files.

QualityHub has regulatory and health care professionals, including medical doctors, who can assist in documenting an HHE. Our professionals understand the data necessary to support effective HHE and how to analyze and organize that data.

QualityHub can assist in developing your procedures for performing HHEs with clear guidance on the escalation to the HHE process from complaints, CAPAs, deviations and non-conformances. We can help your organization prepare in advance for performing an HHE so that when it does become necessary, it can be done quickly and effectively.

Post-Market Risk Management Support

Post-market risk management means carefully monitoring post-market data to:

  • Identify and evaluate new hazards and harms.
  • Assess unexpected changes in the probability of hazards and harms.
  • Evaluate the effectiveness of risk control measures.
  • Determine the need for additional risk controls.

QualityHub has the expertise to configure complaint handling software and risk management databases to optimize data mining and trending capabilities. We can help provide resources to define and implement post-market risk management activities to ensure alignment with applicable risk-management standards.

Learn About Our Expertise in Risk Management

Ready to reduce your risk? Let’s talk.