ISO 10993 Cytotoxicity Evaluation of Medical Devices
The evaluation of the cytotoxicity of a medical device based on ISO 10993 is one of the key milestone for…
The role of management representative according to ISO 13485
Introduction In this post, we will go through the main requirements associated with the management representative role taking into consideration…
IEC 60601 – Overview of the Main Requirements
The IEC 60601 has played and still currently plays a key role for safety of active medical devices. The IEC…
Conformity Assessment for CE marking Process
The conformity assessment can be considered as the procedure through which compliance to the requirements of the MDR is demonstrated.…
Medical Device File according to ISO 13485:2016
The version of 2016 of ISO 13485:2016 has a new requirement compared the previous version which is related to the…
Clinical Evaluation according to EU MDR 2017/745
Clinical evaluation is the assessment and analysis of clinical data of a medical device to verify its clinical safety and…
Packaging Validation for Medical Devices
For medical devices that have to be provided sterile, packaging validation plays an extremely important role. The validation of the…