Everything you need to know to implement the Requirement Management System (RMS) for all levels in the design process

Everything you need to know to get started working with Orcanos system. Orientation, basic functions etc.

Moving forward with your Admin knowledge - Setting up and customizing your system

Getting started with Orcanos electronic document control system.

Getting started with electronic document control system

Learn how to implement ECO management system that meet FDA quality system regulations requirements according to CFR 21 Part 820.

Everything you need to know about how to manage your DMR & DHF electronicly.

Learn how to manage CAPA using Orcanos eForms module

In this course you will learn about the supplier work item in Orcanos eQMS

In this course you will learn about the requirements in regards the design control for product development.

Key consideration when starting digital transformation on your quality events.

Chapter I - Scope and Definitions comprises four articles that lay the basis for the regulations

Welcome to an Introduction to European Union Medical Device Regulations 2017/745. This module is an introductory module to explain how, why and when the new regulations have come into force, what they consist of and some of the new and strengthened features. We will look at some of the historical events that have occurred over a period of decades and their consequences and we will be able to see the triggers for changes in legislation and understand what brought these changes about. This module includes a high-level overview of the contents of EU MDR 2017/745, some of the new features, the timelines for compliance and we’ll take a look at how the new MDRs compare to MDD.

EU MDR 2017/745 - Chapter II - Making Available on the Market