By John E. Lincoln, J.E. Lincoln and Associates
Companies that choose to produce medical products come under the regulatory laws of the countries in which they market their products. For the U.S., this falls under the purview of the U.S. FDA, with its CGMPs, “Current [best practices] Good Manufacturing Practices”, as codified in 21 CFR 4, Combination Products, 21 CFR 111, Dietary Supplements, 21 CFR 211, Pharmaceuticals, and 21 CFR 820, Medical Devices, and others.
For much of the rest of the world, the European Union provides a major model, with its directives, emerging CGMPs, and the ISO quality standards -- ISO 9001 for the majority of quality management systems, and ISO 13485 for medical device QMS.
All these regulatory requirements mandate that a company establish a ‘total quality system,’ from customer requirements through development, procurement (supplier control), production, to customer use and feedback.