ISO (International organization for Standardization) & CEN (European committee for standardsation) are two main professional bodies for formulating standards. Standards can be described as vertical or horizontal, depending on how broad they are. A vertical standard is specific to a device and a horizontal standard applies to a wide range of devices. Example of common horizontal standards are ISO 13485 and ISO 14971. An example of a vertical standard is ISO 7197:2006, which deals with neosurgical implants. Following is a brief discussion about the horizontal standards most often applied to medical device companies. ISO 13485:2003-Quality system: ISO 13485 was adopted in Europe in 1996 and is a modified version of ISO 9001 but with additional requirements especially tailored for the medical device industry. Most people believe that ISO 13485:2003 and many standards in general, is a requirement, but this is not true. It is voluntary in the context of the European directives for medical devices. It is true that you are required to meet the quality system requirements outlined in the directives(Annex 2 and Annex 5 specifically), but how you are going to meet those quality system requirements is left to you, ISO 13485 is a voluntary tool available to you to meet the quality system requirement and there are a number of really compelling reasons to apply ISO 13485.
First, If you are in compliance with ISO 13485:2003, you are presumed to be in compliance with the quality system requirements of these directives. Second why reinvent the wheel? ISO 13485:2003 is designed especially for medical device companies. Third, ISO 13485:2003 is recognized worldwide, and your certification automatically improves the perception of your company and its products. Standards are not permanent and often updated or replaced by new one over the due period.