Honeywell | Life Sciences software

Medical device manufacturers must comply with 21 CFR Part 820, medical device reporting (MDR), premarket notification 510-(k), investigational device exemption, and quality system (QS) regulations.  Audits help manufacturers to improve quality, lower costs, and increase compliance. But, managing them manually can become a time and resource intensive process.

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.

Now more than ever, leading companies are striving to centralize their complaint handling processes to reduce risk, comply with best practices, and streamline operations. Sparta`s complaint handing solutions can be used for documenting, managing, and following up on customer inquiries and complaints and tracking subsequent actions. The system seamlessly integrates complaints with other quality management processeses as well as your CRM and ERP.  An integrated complaint handling solution can help increase customer retention ang regulatory compliance, and lower the risk of product liability lawsuits.