INTRODUCTION TO MEDICAL DEVICES
This introductory course to Medical Devices will walk you through the main aspects of medical device development and the regulatory requirements for Medical Devices around the world.
INTRODUCTION TO ISO 13485
In this training course you will be presented with an overview of the ISO 13485 standard and the main requirements of a Quality System for Medical Device companies.
ISO 14971 – RISK MANAGEMENT
In this comprehensive risk management course you will acquire all necessary skills to create, develop and maintain a Risk Management File for medical devices based on the requirements of ISO 14971.
IEC 62304 MEDICAL DEVICE SOFTWARE – SOFTWARE LIFE CYCLE PROCESSES
In this base course of IEC 62304 you will acquire knowledge on the different aspects of the medical device software lifecycle processes.
CYBERSECURITY AND MEDICAL DEVICES
In this introductory course on the cybersecurity requirements for Medical Devices you will receive a detailed overview of the different regulations, standards, guidance documents and requirements.