FARMINGDALE, NY (08-01-07): Glenn McCarty, CEO of EtQ, recently spoke at the Center for Business Intelligence (CBI) Medical Device Risk Management Summit, held at the Doubletree Hotel in Washington, D.C. on July 16-17.
The medical device & diagnostic industry uses several different models to assess risk. When assigning a risk index to a medical device, the first challenge is to decide the appropriate technique to use. A proper risk assessment is critical to providing the safest and highest quality products. Using the appropriate risk model for your device assists you in meeting your safety and quality goals. The CBI Medical Device Risk Management Summit was held to receive an in-depth analysis of three different models of risk assessment; the Failure Mode Effects Analysis, (FMEA, bottom up method), the Fault Tree Analysis (FTA, top down method) and Hazard Analysis of Critical Control Points (HACCP).
Glenn's presentation, "Techniques for applying Risk-based methods to streamline the CAPA process" provided insights into the growing need to incorporate risk methodologies in order to reduce the number of CAPAs within a system. The session focused on why CAPAs need risk assessment, how to apply risk, and real-world examples of how using this technique can benefit a quality system. "Using risk assessment, companies in all industries are able to filter out the critical events versus non-critical events and dedicate more energy and resources to the events that have the most impact on the business."
The conference was a huge success in identifying leading concepts in the medical device industry regarding risk assessment and risk management. EtQ continues to participate in these conferences and summits in an effort to help industry professionals seek new methods for automating and simplifying their quality and compliance processes.
EtQ is the leading Enterprise Quality and Compliance Management Software for identifying, mitigating, and preventing high-risk events through integration, automation, and collaboration. EtQ uses best-in-class, integrated modules and enterprise application integration to manage and measure quality and compliance processes and execute organizational change. Key modules within the product include: Document Control, CAPA (Corrective and Preventive Action), Audit Software, Complaint Handling, Risk Management, Change Management, Employee Training, Project Management, Nonconforming Materials, Enterprise Reporting, and more than 20 additional compliance-oriented modules. With its world-class flexible workflow, collaborative platform, EtQ has developed a unique niche to support enterprises involved in various compliance management initiatives such as; cGxP (FDA), ISO 13485, ISO 9001:2008, ISO/TS 16949, ISO 14001, ISO 22000, AS 9001, TL 9000, OHSAS 18001, RoHS, Sarbanes-Oxley, HACCP, SQF and similar standards for compliance and regulatory management. EtQ has been providing compliance solutions to a variety of markets for over 15 years.
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