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, MDF & DHF electronicly.

Edition II (Nov. 2023) 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.

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.

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

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

This course focuses on providing an understanding of the U.S. Food and Drug Administration’s current Good Manufacturing Practices (cGMP) regulations for equipment used for medical devices/drug manufacturing and related processes.

This course is perfect for those overwhelmed by managing project requirements in Excel or Word, especially as projects grow and involve more stakeholders. It covers everything from Version Control and Change Management to identifying Dangling, Orphan, and Suspect requirements. You'll learn how to manage change effectively, understand the impact before proceeding, and ensure all relevant parties are informed and agree. The course equips you with a world-class requirements management tool and framework, plus 6 months of free access to Orcanos software for practical experience. Key learnings include managing complex projects, understanding and applying Requirements Management and Traceability, setting up a top-tier requirements management plan, and mastering advanced concepts like approval workflow. It's designed for Business Analysts, Product Managers, Systems Engineers, Project Managers, and Program Managers, with no prior experience required.