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…
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 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…
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…
Document Control Procedure
For any type of quality management system, whether within the medical device sector or not, having an established document control…
Device Master Record
The device master record is a design document specifically requested by the FDA Quality System Regulation, as per 21 CFR…
How to write a Quality Manual fully compliant with ISO standards?
The quality manual is one of the most important documents for a company with a quality system in place, and…
ISO 62366 and Usability Requirements for Medical Device
ISO 62366 plays a fundamental role in the design process for medical device as it explains the requirements related to…
