Medical Device Risk Management

Risk Management for Medical Device Companies

The Sparta risk management solution enables companies to link risk management processes to other quality management processes. This ensures that nonconformities, regardless of source, are evaluated using consistent criteria and standards such as ISO 14971.  Additionally, it can trigger updates to review the product risk register to have a truly closed-loop process. The solution is fully configurable, allow you to identify, measure, quantify, and classify risk globally. It allows you to focus on the areas of highest risk, while continuing to monitor occurrences of lower-risk nonconformities.

Risk Management Solution Benefits

  • Ensures compliance with regulations and standards like 21 CFR Part 820 and ISO 14971. 
  • Decreases cost of quality by allowing resources to focus on the areas of highest risk.
  • Allows consistent, structured classification of risk using a company’s own criteria and terminology. 
  • Incorporates consistent risk management across nonconformances, customer complaints, and audit findings, and helps determine whether CAPA is needed. 
  • Increases the consistency of risk classification by providing user-friendly features such as built-in decision trees and drill-down selection lists. 
  • Links to design and change control activities to ensure nonconformities  are integrated back into the design cycle, and PLM system wherever appropriate. 
  • Supports risk management tools such as FMEA, FMECA, risk ranking, scoring, filtering, and trending to manage risk in medical device companies.

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