Courses in Cardiff

This module provides an introduction to the basics of medical device regulation, especially the requirements that manufacturers must meet in order to market devices in Europe and the USA.

Master the European Medical Device Regulations (EU MDR) with this comprehensive course. Gain the knowledge and skills you need to comply with the EU MDR and successfully bring your medical devices to market.

21CFR11 applies to records that are required to be submitted to the FDA, or that are subject to FDA inspection, and that are in electronic form – that is, as computer files. It applies to all computer systems used to create, modify, maintain, archive, retrieve, or transmit such records – from a humble spreadsheet program to a complex information management system.

Explore the essentials of European Medical Device Regulations (EU MDR) with our comprehensive course. Gain insights into regulatory requirements, quality systems, and reporting protocols to ensure compliance in the healthcare industry.