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. The conformity assessment is the mandatory step that needs be
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 so-called Medical Device File. The medical device file (MDF) is
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 performance. The evaluation is based on a comprehensive analysis of
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 packaging processes might involve different players, not only the manufacturer,
Clean Room Validation
Clean room validation is nowadays essential for medical device manufacturers of sterile devices; sterility of the devices has a direct impact on patient safety and product quality. Building a cleanroom
