This is an individual standard for the quality management of medical products. It comprises all GMP principles (good manufacturing practice) which are applied during the production of medical products. They have to meet various regulation systems, national and international standards and other requirements. By producing medical products you are responsible to always supply safe and efficient products.
If your company applies this standard you meet the regulation of medical products. Thus you develop and produce products conforming to international standard. Meeting national guidelines, standard and laws will protect against claims resulting from product liability.
Update version:ISO 13485:2003