No doubt, obtaining marketing approval for your product is a major achievement. However, this achievement is not sufficient. As developer, manufacturer or distributor of the product, you also have to demonstrate that you possess the capability to maintain high quality procedures. The device you manufacture and distribute today has to be essentially identical in all aspects to the device that you will manufacture 3 years from today. How do you assure such high quality standard?
The answer is simple - the medical device industry, and the medical regulatory authorities, drawing on the vast experience gained during the last decades, have issued sets of quality standards. You need to possess these standards and act upon them right from the early stages of the development, through the entire life-span of the product. Periodic audits by officials of the European, American and other regulatory authorities are aimed to ascertain full compliance with these standards.
Although the basic demands are common, there is no universal standard. You should be equipped with the standards issued or accepted by the authorities of your target market.

• The European authorities accept the ISO 9001:2000 and the ISO 13485:2003 quality standards. These standards are valid in each of the European Community countries, and apply in conjunction with the 93/42 EEC Medical Device Directives.
  
  
• The American regulatory agency, the FDA, has published the Quality System Regulation (QSR) standards.
  
  
• The Canadian ministry of health has published a Medical Device Regulations document, that references the ISO 13485:2003
  
  
• Other countries might have specific standards, which can be implemented upon request. Click on the corresponding colored button if you want to know more on CE QMS Requirements, FDA QMS Requirements, or CMDCAS QMS Requirements