Apps and Software as Medical Devices

Who should attend

This introductory course is of value to employees at all levels within the organisation of Medical Device manufacturers, and suppliers to the Medical Devices industry including:

• Members of the senior management team
• Software Engineers
• Apps Developers
• Regulatory Affairs professionals
• Quality Assurance professionals
• Development engineers
• Technical Sales & Marketing professionals

Course Outline

The medical device industry has over the last two years witnessed a phenomenal rise in innovative software applications. The proliferation of smart phone and tablet technology – whether from Apple or her Android or other platform counterparts – has fuelled the rise of innovative uses within the medical devices industry.

There are now apps available that contribute to the treatment of diabetes, apps that facilitate the transfer of lab results and apps that help detect cognitive disorders. There is also other stand alone software that can be considered to be a medical device under the Medical Device Directive regulations.

This highly topical and relevant course is intended to explain clearly how to decide whether an app, or other form of software, is a medical device as defined by the European Regulations and, if so, how to classify it and comply Medical Devices Directive and therefore remain in compliance with the relevant laws.

Topics covered

• Brief history and overview of the Medical Devices Directive 93/42/EEC
• How to decide if software is a Medical Device
• How to classify the software under the Directive
• The information that a Manufacturer/Developer has to generate and provide
• How to build a technical file for a device which is software
• Intended use and device description
• Essential Requirements of the Directive
• Software identification
• Instructions for the user
• Risk Management
• Post Market Surveillance of device performance
• Vigilance
• Software Development Lifecycle
• Operating System updates and how to handle them
• An appreciation, knowledge and understanding of the main requirements of the directive and when software is classified as a Medical Device
• An understanding of the additional requirements for software-based medical devices
• Mechanisms for determining device classification for software
• Understand the role of regulatory bodies
• Understand how to satisfy the Essential Requirements of the Directive
• Contents of the “Technical File” for a software-based device
• Integration of Risk Management throughout the development process and beyond
• Post production obligations

Outcomes

• An appreciation, knowledge and understanding of the main requirements of the directive and when software is classified as a Medical Device
• An understanding of the additional requirements for software-based medical devices
• Mechanisms for determining device classification for software
• Understand the role of regulatory bodies
• Understand how to satisfy the Essential Requirements of the Directive
• Contents of the “Technical File” for a software-based device
• Integration of Risk Management throughout the development process and beyond
• Post production obligations