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…
Methodologies for Training Effectiveness
Training effectiveness is one of the key requirements associated to Quality Management System according to ISO 13485. Having adequate methodologies…
Design and Development Plan
In this article, we want to give you a deep dive into the requirements associated to the Design and Development…
Complaint Handling Process for Medical Device Manufacturers
The complaint handling process for medical device manufacturers is of fundamental importance for multiple reasons. Surely, compliant process is directly…
