ALM | Product Realization ISO 13485 Module 7 (Part A)

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

• Course
• By Rami Azulay

Advanced Admin in Orcanos

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

• Course
• By Elika Goldwasser

Document Control Module (Admin)

Getting started with electronic document control system

• Course
• By Rami Azulay

EU MDR 2017/745 Training (PART I): Introduction

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.

• Course
• By Yuval Shapiro

Getting Started with Orcanos (Admin)

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

• Course
• By Elika Goldwasser

Getting Started with Orcanos (User)

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

• Course
• By Amalia Tammam

How to Manage DMR/DHF/MDF

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

• Course
• By Rami Azulay

Implementing ECO/DCO Management Module

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

• Course
• By Rami Azulay

Module 1: EU MDR 2017/745 Training - Chapter I - Scope and Definitions

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

• Course
• By Yuval Shapiro

Module 2: EU MDR 2017/745 - Chapter II - Making Available on the Market

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

• Course
• By Yuval Shapiro

Product Requirement Management & Traceability

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.

• Course
• By Rami Azulay

Return Merchandise Authorization Module

This course provides a comprehensive overview of the Returned Merchandise Authorization (RMA) process specifically tailored for regulated industries, such as pharmaceuticals, medical devices, and food production. Participants will learn about the critical compliance requirements, documentation standards, and best practices for managing product returns in accordance with industry regulations. Through case studies and practical examples, the course will equip attendees with the skills to efficiently navigate the RMA process, ensure product traceability, and maintain regulatory compliance while minimizing risks associated with returned products. Ideal for professionals involved in quality assurance, regulatory affairs, and supply chain management, this training will enhance understanding of the interplay between effective RMA practices and regulatory adherence, ensuring safe and effective handling of returned merchandise.

• Course
• By Rami Azulay

Risk Management to Medical Device

• Course
• By Rami Azulay

Steps for Implementing a Quality Management System—the Successful Way!

Key consideration when starting digital transformation on your quality events.

• Course
• By Rami Azulay

Supplier Qualification

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

• Course
• By Rami Azulay

Using Document Control Module (User)

Getting started with Orcanos electronic document control system.

• Course
• By Rami Azulay

What Medical Device Manufacturers Can Learn from 21 CFR Part 211 Subpart D - Manufacturing Equipment Management

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.

• Course
• By Rami Azulay

eQMS - eForm - ISO 13485/21 CFR Part 820 Subpart J - Corrective and Preventive Action CAPA Management (User)

Edition II (Nov. 2023) Learn how to manage CAPA using Orcanos eForms module.

• Course
• By Amalia Tammam