The Risk Benefit Analysis
The benefit risk analysis is one of the key elements of the risk management process for medical devices and, more…
Software as Medical Device (SaMD) : What Do you Need to Know?
SAMD – Software As Medical Device became more and more spread within the healthcare. The worldwide spread of software applications…
Requirements Traceability Matrix
Traceability for Software Validation Activities In the framework of software validation, it is of fundamental importance to maintain full traceability…
Design Transfer: A practical Approach
In the framework of the process of Design and Development, the design transfer (DT) corresponds to the last phase, where…
ISO 17664: Processing Instructions for Medical Devices
In the last years, the reprocessing of medical devices started to play a critical role and additional requirements have been…
ISO 2859 and AQL Sampling Methodology
Over the course of time, the ISO 2859 standard has established itself as an indispensable tool, not only for medical…
Cleaning Validation : Overview of the Main Requirements
In the current practice, the process of cleaning validation became essential for the life science sector, especially for the pharmaceutical…
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…
ISO 19011 : Guidelines for Auditing
Regulated environments as medical devices or pharmaceutical sectors requirer the organisations to undergo audits from notify body or competent authorities;…
ISO 13485 Audit Checklist
Internal audits are one of the most important process within a Quality Management System for Medical Device manufacturers and having…