At Toxway, we specialize in developing and implementing comprehensive Risk Management Plans (RMPs) in strict alignment with ISO 14971 standards. Our RMPs are designed to take a proactive approach to risk management, encompassing the entire lifecycle of medical devices—from initial design and development through to post-market surveillance.

Our RMPs begin with a thorough identification and evaluation of potential risks associated with your medical device. This includes a detailed analysis of hazards, assessing their likelihood, potential impact, and the implications for patient safety and device functionality. We then establish and implement risk control measures to mitigate these risks, ensuring that every identified hazard is addressed effectively.

The plan integrates systematic procedures for ongoing risk assessment throughout the product lifecycle, ensuring that risks are continually monitored and managed as the device evolves and as new data becomes available. This proactive management approach not only helps in maintaining compliance with regulatory requirements but also supports the operational success of the device.

In addition to safety, our RMPs focus on ensuring that the device meets international safety standards and regulatory expectations. We ensure that risk management activities are documented comprehensively, providing clear evidence of the steps taken to mitigate risks and maintain safety.

By employing a structured and thorough approach to risk management, Toxway helps manufacturers minimize potential risks while preserving device functionality and safety. This approach not only enhances regulatory compliance but also supports long-term operational success, ensuring that your medical device remains safe and effective throughout its lifecycle

For more information about our services or to request a consultation, contact us at info@toxway.com