Training Overview
Twenty-five years ago, software did not feature significantly in medical device legislation. Thirteen years ago it was added as a serious afterthought. As Europe moves to the new Medical Device Regulations, software is recognised throughout the General Safety and Performance Requirements. It has its own rules in classification, whether it is software as a medical device or software as the driver of a medical device. Software has come to the attention of the regulators as a serious source of risk and benefit. This sequence of seminars aims to help those involved in medical device software to understand intricacies of the regulatory burden and how early adoption of the solutions minimises both the costs and time to market.
Key Topics:
• How Medical Device Software is defined
• The State of the Art from a regulatory perspective
• Software classification, the Regulations and the Medical Device Standard EN 62304
• Risk class
• Risk analysis of software
• The Unique Device Identifier
• Active implantable devices
• Labelling, Instructions for use
• Clinical Evaluation & Performance Evaluation Report
• Post-Market Surveillance and Vigilance
Who should attend?
Those who are involved in any of the following:
• Writing software for Medical Devices or writing software as a Medical Device
• Implementing the EU Medical Device Regulation in their organisation
• Writing technical files or quality systems for the EU Medical Device Regulation
• Quality Engineers or Regulatory Affairs professionals
Trainer
