Medical Device Software Requirements: A Regulatory Overview

Agenda

Medical device software is evolving and growing exponentially. Medical technology (medtech) companies manufacture more than 500,000 different types of medical devices, including wearable external medical devices (skin patches, insulin pumps and blood glucose monitors), implanted medical devices (pacemakers and implantable cardioverter defibrillator devices) and stationary medical devices (home monitoring devices, connected imaging devices and scanning machines) each with a software function as part of their makeup. Getting a software device to market and then maintaining it is extremely challenging. Once developed software is constantly changing to stay up to date with the latest operating systems or security issues. Notified Bodies and Regulators want to see how you are maintaining a high-quality product that puts the end user’s safety first.                                                             This training course will provide you with solutions to the regulatory challenges you face when working with software as a medical device. Once completed, you will have the knowledge to know what must be done to meet Notified Body/ Regulatory requirements. You will briefly touch on aspects unique to software in major regulatory/development areas such as clinical evaluations, investigations, labelling, post market surveillance and risk management                                                                                                                     Module 1: Software overview and definitions of your software a device?                                                                                                                       

• Review the Regulations  and Examine the definitions and intended use of your device

Module 2: Bringing medical device software to market

• Examine the regulatory requirements to put a medical device software on the market.
• Examine the Medical Device Regulation (MDR) and FDA systems

Module 3: Usability and Risk management for medical device software

Safety risk management – ISO 14971

Applying an effective risk management strategy for medical device software

Design inputs

 Module 4: Development of medical device software

Usability

Operating environments

Cyber security

Maintenance

SAMD and embedded software

Document structure

 Module 5: Maintenance strategies

Platforms and keeping up to date

What are significant changes

 Post market considerations and regulatory maintenance

Learning Objectives

Delegates attending this Medical Device Software Requirements: A Regulatory Overview Training Course will be able to

• Understand the basic regulatory requirements for device software
• Understand the common challenges faced by manufacturers with software
• Learn how best to overcome those challenges with practical knowledge and advice
• Gain practical skills for bringing a software device to market
• Be aware of major development hurdles and how to overcome them