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…
Common Specifications according to EU MDR 2017/745
What are Common Specifications? The definition of common specifications according to the EU MDR and IVDR is “ set of…
EU MDR QMS Requirements : An Overview
Introduction to MDR QMS Requirements A complete and comprehensive understanding of the EU MDR QMS requirements is becoming essential for…
Summary of Safety and Clinical Performance (SSCP) according to EU MDR
As we know, the European Medical Device Regulations introduced in new requirements for medical device manufacturers, especially in the field…
Vigilance Reporting Requirements according to EU MDR 2017/745
Introduction Vigilance reporting is one of the pillars of post-market surveillance process for medical device. It belongs to the so-called…
PRRC (Person Responsible for Regulatory Compliance) and the EU MDR
The PRRC (Person Responsible for Regulatory Compliance) is one of the new requirement of the EU MDR European Medical Device…
Periodic Safety Update Report (PSUR) according to EU MDR 2017/745
One of the new requirement introduced with the EU MDR 2017/745 is the one related to the preparation of the…
The PMCF (Post-Market Clinical Follow-Up) according to EU MDR 2017/745
The PMCF – Post Market Clinical Follow-up is part of active modalities to perform post-market surveillance activities and the requirements…