Medical device quality

Chapel Hill, North Carolina – Best Practices LLC officials have initiated its third bi-annual study on management approaches that leading medical device companies utilize to improve efficiency and increase effectiveness in all aspects of their Quality operations.   

Quality function effectiveness represents a top concern in the fast-growing medical device industry, as companies are keenly aware of the focus on patient outcomes, regulatory issues, product recalls, and these issues impact on long-term financial stability.

This study will help participating companies understand whether their Quality investments are sufficient and whether resources are allocated effectively across activities at every stage of the product life cycle, from development through post-market activity.

This comprehensive online survey will provide participating Quality leaders with current, evidence-based metrics and insights that are critical within the current environment of tight budgets and escalating regulations. The resulting report, provided for free to all participants, will include reliable industry metrics on 2014 Quality spend, allocation levels for key Quality activities, staffing levels, outsourcing/offshoring practices, approaches to rapid M&A integration, and volume of change requests, complaints, CAPAS, and NCEs.

Survey participants will receive the full study results free within a few weeks of the close date, projected for Jan. 19, 2015. Participants in two previous editions of this work have used the results to improve quality practices, drive cost efficiency, develop new strategies, and better manage organizational risk.

Quality function process and activity areas probed in this research will include:

• Compliance: Document controls, quality management review, quality audits, quality training
• Inspection/Production: Software quality, supplier quality, inspections, product release, laboratory testing sterilization, toxicology, and biocompatibility, calibration
• Nonconforming: Complaints handling, CAPAs/nonconforming events, corrections, and removals
• Other: Product design support, quality engineering, one-off projects, corporate quality system administration, etc.

There is no cost to participate in the Quality study. This research is open to executives, directors, and managers in the medical device and diagnostics sectors who are responsible for Quality, compliance, inspection, complaints, nonconforming events, or any other quality-related activities.

Click here to participate in the study and see contact information for the project leader.

Source: Best Practices LLC