Building traceability into the medical device development process is crucial for compliance. Designing a medical device is a complex task that requires meticulous documentation and collaboration, as there is no margin of error. Failures in device design can lead to catastrophic consequences, which is why risk management plays an important role in medical device development. To design safe and efficacious products for patients, comprehensive risk management and traceability for compliance must be involved at each stage of the product lifecycle: process, production and post-market use.
Learn more about how integrating Comprehensive Risk Management to achieve design excellence can help medical device manufacturers achieve traceability.
Integrate end-to-end risk management
Medical device manufacturers are no strangers to the ever-changing regulatory landscape that increases the scope of compliance. These companies are held accountable for the products they bring to market. Design control guidance for medical device manufacturers ensures the best quality practices are implemented worldwide. In fact, the standard ISO 14971 was specifically created to establish a process for risk management and how to analyze, control and monitor potential hazards for medical devices.
Now more than ever, medical device companies require risk management solutions tailored to their needs. Risk management should not only be ingrained in appropriate documentation but also in the logical, digital data elements that feed into design input and verification and validation. Seamless integration of these risk elements and files allows for end-to-end risk management.
Read the infographic to learn more about Comprehensive Risk Management as part of our Design Excellence solution for medical devices.