The evaluation of the cytotoxicity of a medical device based on ISO 10993 is one of the key milestone for the introduction of new devices on the market, thus

Introduction In this post, we will go through the main requirements associated with the management representative role taking into consideration one main standard: ISO 13485 - Medical devices — Quality management systems

The IEC 60601 has played and still currently plays a key role for safety of active medical devices. The IEC 60601 is basically a group of standards which is dealing

The conformity assessment can be considered as the procedure through which compliance to the requirements of the MDR is demonstrated. The conformity assessment is the mandatory step that needs be

The version of 2016 of ISO 13485:2016 has a new requirement compared the previous version which is related to the so-called Medical Device File. The medical device file (MDF) is