The main challenges in this process include identifying potential hazards, estimating and evaluating the associated risks, controlling these risks, and monitoring the effectiveness of the controls implemented.
Proper risk management is crucial to prevent harm to patients and users, ensure regulatory compliance, and maintain market access.
Our medical device team offers comprehensive risk management services tailored to the unique needs of your device.
We handle risk management in multiple ways
What can we do for you?
Our medical device team can engage with you at any stage of the device lifecycle, from initial development to post-market surveillance. Whether you are developing a new device or managing an existing one, we are here to ensure your risk management process is robust, compliant, and effective.
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- Understanding Your Product: We begin by thoroughly understanding your medical device, including its intended use, user profile, indications, and potential clinical benefits. This foundational knowledge is critical for identifying relevant hazards and risks.
- Identifying Standards and Guidelines: We will identify all applicable standards and regulatory guidelines, particularly ISO 14971, to ensure your risk management process complies with international and regional requirements.
- Risk Identification and Analysis: Using various tools and techniques, we will identify potential hazards and analyze the associated risks. This involves estimating the severity and probability of harm and documenting these findings in a risk analysis report.
- Risk Evaluation and Control Implementation: We will evaluate the identified risks to prioritize them and implement risk control measures. This may involve design changes, protective measures, and providing safety information to users.
- Residual Risk Assessment: After implementing risk controls, we will assess the residual risks to determine their acceptability. If necessary, additional risk control measures will be implemented.
- Design Impact as an outcome of Risk Management: After completing the risk evaluation, we will decide with you whether or not all risks are acceptable and if any adjustment is needed to your product.
- Documentation and Communication: Throughout the process, we will maintain detailed documentation in the risk management file. This includes the risk management plan, risk analysis, risk evaluation, risk control measures, and residual risk assessment.
- Ongoing Risk Management: Risk management is a continuous process. We can support your post-market surveillance activities to monitor and manage risks associated with your device after it has entered the market. This ensures that any new risks are promptly identified and mitigated.