The EN ISO 13485:2003 "Medical products, quality management systems, requirements for regulatory purposes” was released in November 2003 and harmonized in 2004. It is a structured management system that safeguarding product conformity and ensuring that a manufacturing or design process can consistently produce product of the required standard. With regards to medical devices, there is no standard that better represents the requirements for a comprehensive management system than ISO 13485:2003. Compliance with ISO 13485:2003 is often seen as the first step in achieving compliance with regulatory requirements.
Increasingly, certification to ISO 13485:2003 is becoming the preferred method for medical device manufacturers and their sub tier suppliers/contractors to demonstrate the intent to comply with applicable regulatory and statutory requirements. Medical device manufacturers who are placing their products on the market within the European Union will need to address compliance with the requirements of the applicable Medical Device Directive (MDD) and the CE marking process. ISO 13485:2003 is recognized as an aid in supporting compliance with the MDD.
Certification to ISO 13485:2003 is not only used by medical device manufactures as the foundation to their management system, it is also used by non-medical device companies as a first step to gain new business opportunities within the medical device community.