There is also a similar directive for AIMD and IVDD. In the European market, devices must have approval for the CE Mark in accordance with one of the three device directives: the Medical Device Directive (MDD), Active Implantable Medical Devices (AIMD), or In Vitro Diagnostics Directive (IVDD).
ISO 13485 COMPLIANCE ISO
You might also review comparison tables from the IMDRF website ( ) to help you identify differences between the ISO 13485 Quality System documentation and international regulatory requirements.
ISO 13485 COMPLIANCE MANUAL
Therefore, we recommend the following step-by-step approach: The basic foundation for achieving regulatory compliance is ISO 13485, but each of the three markets has additional regulatory requirements that must be incorporated into the QMS. If you are doing this for the first time, this is a daunting task. The key to managing multiple markets is to create one Quality Management System (QMS) that meets the requirements for all your target markets. Three separate quality systems would be inefficient and confusing.