Risk Management for Medical Device Manufacturers

TrackWise risk management functionalities enable companies to integrate risk management processes across their entire quality management system. This ensures that nonconformities, regardless of source, are evaluated using consistent criteria to determine risk using standards such as ISO 14971 – the international standard recognized as the best process to ensure that all aspects of risk management are considered throughout the product lifecycle for medical devices. Additionally, this can trigger updates to review the product risk register to have a truly closed-loop process.

TrackWise provides an enterprise risk management solution for medical device companies by offering a fully configurable platform to identify, measure, quantify and classify risk globally. This ensures that medical device manufacturers can focus their resources on the areas of highest risk, while continuing to monitor occurrences of lower-risk nonconformities. 

• Designed to ensure compliance with government regulations and industry standards, such as 21 CFR Part 820 and ISO 14971  
• Decrease cost of quality by allowing your resources to focus on the areas of highest risk  
• Allow consistent, structured classification of risk using your own criteria and terminology  
• Incorporate consistent risk management across quality management systems; manufacturing nonconformances , customer complaints , and audit findings  utilize the same criteria to ascertain risk and determine whether CAPA  is needed  
• Increase the consistency of risk classification by providing user-friendly features such as built-in decision trees and drill-down selection lists  
• Seamless integration to design and change control activities to ensure nonconformities to marketed products are integrated back into the design cycle, including integration  to PLM where appropriate 
• Support risk management tools such as FMEA, FMECA, risk ranking, scoring, filtering, and trending to manage risk in medical device companies