Expedite Readiness for Regulations and Requirements

To ensure patient safety, medical device manufacturers must establish and follow quality systems to meet requirements specified by the U.S. Food and Drug Administration (FDA). Quality systems for FDA regulated products follow current good manufacturing practices (CGMP) as laid out under FDA 21 CFR part 820. Complying with these mandates is a key objective of quality leaders, but many underestimate how significantly their work impacts other teams.

More companies involved with design, production, installation, and servicing of medical devices are expected to demonstrate their quality management processes by following the internationally agreed standard, ISO 13485, which specifies requirements for quality management systems. It’s important to note that in the newest version of the ISO standard, it places “greater emphasis on risk management and risk-based decision-making for processes that extend beyond the realm of product realization.”

These primary objectives bring us to two important points:

1. Efforts and actions that focus on meeting FDA and ISO standards should not be carried out or managed in isolation
2. To effectively compete, medical device manufacturers need to adopt holistic, connective QMS approaches to provide better traceability

Organizations that exemplify these points see quality as important beyond just compliance—setting the stage for continuous improvement, a learning culture, supply chain collaboration, and greater customer satisfaction.

Let’s look closer at how quality and operations leaders can help their teams and their organizations realize these rewards.

Additional Resources

• Driving Quality Across Supply Chain to Highest Levels
• FDA – Quality System (QS) Regulation & Medical Device Good Manufacturing Practices
• ISO 13485 – Medical Devices
• Orthopedic Design & Technology – A RiskBased Approach to QMS