In the framework of the process of Design and Development, the design transfer (DT) corresponds to the last phase, where the specifications are basically transferred to the manufacturing environment to

Over the course of time, the ISO 2859 standard has established itself as an indispensable tool, not only for medical device manufacturers, but also for a wide range of manufacturing

Internal audits are one of the most important process within a Quality Management System for Medical Device manufacturers and having an ISO 13485 Audit Checklist is an essential

Training effectiveness is one of the key requirements associated to Quality Management System according to ISO 13485. Having adequate methodologies for delivery of training and evaluate effectiveness of this training

In this article, we want to give you a deep dive into the requirements associated to the Design and Development Plan. As you know, the Design Process for medical devices