Helping medical device organisations identify, evaluate and control product risks through a structured risk management approach that remains active throughout the device lifecycle.
Risk management is not a one-time assessment completed during product development. Medical device organisations need a consistent process for identifying hazards, evaluating associated risks, implementing appropriate controls and reviewing new information as the device evolves.
Establishing an ISO 14971-aligned risk management process
Identifying hazards and evaluating device-related risks
Reviewing the effectiveness of implemented risk controls
Updating risk documentation when new lifecycle information emerges
Identify foreseeable hazards, hazardous situations and associated risks to build a clear understanding of potential safety concerns.
Evaluate identified risks against defined criteria and establish appropriate control measures to reduce risks where required.
Review production, post-market and other relevant information to determine whether existing risk assessments and controls remain appropriate.
Effective risk management requires more than maintaining a standalone risk file. DnA Regulatory Solutions helps organisations connect risk activities with design, clinical, usability, software and post-market evidence so that changes and new safety information can be assessed consistently.
Maintain traceability between hazards, risks, controls and verification evidence
Review residual risks and support benefit-risk evaluation where applicable
Feed relevant production and post-market information back into risk documentation
Risk Management Continues Beyond Development:
Device risks can change as new information becomes available. A structured ISO 14971 approach helps organisations reassess assumptions, evaluate emerging information and maintain risk controls throughout the product lifecycle.
ISO 14971 provides a structured framework for identifying hazards, estimating and evaluating associated risks, controlling those risks and monitoring the effectiveness of risk management activities throughout the medical device lifecycle.
Risk management should begin during device development and continue through production and post-market activities. New information, design changes, complaints and other relevant findings may require existing risk assessments to be reviewed.
Risk management can interact with design and validation evidence, usability, clinical evaluation, software activities and post-market information. Maintaining these connections helps keep safety evidence consistent as the device evolves.
Build a structured approach to identifying, controlling and reviewing medical device risks with documentation that remains connected as new evidence emerges.