Safeguarding Patients and Ensuring Compliance
At Sushvin, we understand that effective risk management is crucial to the success of any medical device. Our comprehensive risk management services ensure that potential hazards are identified, assessed, and mitigated throughout the entire product lifecycle, ensuring the safety and efficacy of your medical device.
What is Risk Management?
Risk management in the context of medical devices and IVDs involves the systematic identification, evaluation, and control of potential hazards that could impact the safety and effectiveness of your products. It is a fundamental requirement outlined in standards such as ISO 14971, which governs risk management processes for medical devices.
Why Risk Management Matters?
Effective risk management is vital for ensuring the safety and performance of medical devices. It plays a crucial role in regulatory compliance by identifying and mitigating potential hazards that could affect patient safety and device effectiveness. By systematically managing risks, manufacturers can avoid costly recalls, enhance product quality, and ensure adherence to regulatory standards.
Our Risk Management Services
We perform comprehensive risk assessments to identify potential hazards associated with your medical devices or IVDs as per ISO 14971. Our approach includes:
Once risks are identified and evaluated, we assist in developing and implementing risk control measures as per ISO 14971, including:
Our team can help create a tailored risk management plan that outlines the processes, responsibilities, and methodologies for managing risks throughout the product lifecycle. This plan serves as a critical reference for your organization and regulatory authorities.
Our team can assist you in creating the necessary risk management documents for your medical device or IVD. This includes the risk management plan, hazard identification, risk analysis, risk management report, and benefit-risk analysis.
Risk management is not a one-time task. We provide services for ongoing risk monitoring and review to ensure that risks are continuously assessed and managed, especially in response to:
We offer customized training sessions to educate your team on risk management principles, methodologies, and regulatory requirements. Empowering your staff with knowledge ensures that risk management is integrated into your company culture.
Key Aspects of Risk Management
Why Choose Us?
Get Started Today!
Ensure your medical device or IVD is safe and compliant with our expert risk management services. Contact us today to schedule a consultation, and let’s work together to safeguard your product and its users.
Reach out today to discover how Sushvin's team can assist you.
