Pharma services and solutions

Supply chain: Complaint management

The challenge

When it comes to medical devices, patient safety is the number-one priority of the FDA, device manufacturers, patient advocacy groups and, most importantly, the patients themselves. Complaint handling not only helps device manufacturers manage product safety, it provides direct product feedback that companies can use to improve their products and services.

In the United States alone, noncompliance penalties include individual fines in excess of $100 million. In a large sampling of 318 FDA warning letters issued between 2005 and 2009, 79 percent were related to complaints or medical-device reporting. Most findings indicate:

• Lack of complaint-handling procedures
• Inconsistent processes
• Lack of complete analysis
• Failure to properly submit medical device reports

How we can help

An efficient complaint-handling system can improve customer loyalty and retention and have a positive impact on your company's reputation. We can help you integrate complaint management with a corrective and preventive action system. We also can help you standardize a compliant medical device reporting process. Our experienced pharmaceutical, life sciences, and medical device professionals can work with you to design a streamlined, harmonized process and functional organizational model to support the global management of product complaint information across your company's product lines.

Common services include:

• Quality management system assessment
• Company complexity and risk analysis
• Complaint-handling technology selection and integration
• Medical device reporting analysis, planning, implementation, and process integration
• Analysis of historical complaint data and industry and sales trends