General Safety and Performance Requirements (GSPR)
Several new requirements and topics have been introduced in medical device regulations, emphasizing the importance of specific minimum essential product…
European General Data Protection Regulation (GDPR)
With the digital medical devices being more and more spread all over the world and being further pushed by Covid…
Customer Related Process according to ISO 13485
The requirements for customer related process are reported in the section 7.2 of the ISO 13485:2016. Customer related processes are…
Gamma Sterilization Process for Medical Devices
Gamma sterilization is extensively used in the life science sector and more specifically in the medical device sector, where gamma…
Strategy for Regulatory Compliance according to EU MDR 2017/745
Having a Strategy for Regulatory Compliance is a new requirements clearly mentioned in the European Medical Device Regulation (EU MDR…
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…
