The PDCA Approach: Plan, Do, Check and Act
The PDCA cycle stays at the base of any quality management system and it is an extremely important approach useful…
Legacy Devices and EU MDR Requirements
In this specific moment where the new EU MDR 2017/745 is officially entered into force, the management of the so-called…
Implantable Medical Devices and related EU MDR Requirements
Implantable medical devices are usually highly risky devices for which a potential failure may cause serious consequences to the patient.…
Custom made Devices according to EU MDR 2017/745
The concept of custom-made devices is surely not new and many competent authorities have specific requirements in place to regulate…
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…
