Solutions for many issues faced by medical device manufacturers could be well followed by other manufacturers. Many of these approaches could help with any product where quality is important, including most manufactured products.

At a recent meeting of Medical Device and Manufacturing (MD&M) in Minneapolis,there was considerable interest in the topics of:

• QMS (Quality Management System)
• Risk management
• Process mapping

ISO AND U.S. STANDARDS FOR QMS
Manufacturers of medical devices for use within the U.S. must have a QMS that complies with Federal Regulation 21CFR-820. Devices for use in most of the rest of the world must comply with ISO Standard 13485:2003. Both the Federal Regulation and the ISO Standard place a collaborative responsibility on demonstrating appropriate and adequate medical device cleaning as part of their risk managementprogram and as part of the QMS.

The ISO and U.S. standards are complementary, not conflicting. There is a very large amount of overlap.1This means that a company can fairly easily develop a QMS to comply with both the ISO standard and the Federal regulation. The U.S. regulation is more specific or pointed in requiring the reporting to and communication with regulatory agencies. Figure 1 is a schematic of many of the elements that feed into a comprehensive QMS.

For complex devices where fabrication and assembly occur at two or more locations (sometimes in two or more companies), a greater emphasis on cleaning and contamination control and a greater transparency among companies will be called for. Achieving those two goals will require a paradigm shift.