FDA's Latest Guidance for Cybersecurity for Medical Devices: Quality Management System and Premarket Submission Considerations 

Overview

This webinar will focus on cybersecurity of medical devices, a key concern for those who develop, manufacture, test, and distribute these products. Protecting medical devices from hacking where someone can alter the actual code embedded in the device could result in injury or death to a patient or consumer. A serious threat, it must be dealt with at all levels to make sure the end product being used by a patient or consumer is perfectly safe and delivers the effective treatment required.

Why Should You Attend

Providing safe and effective medical devices is in the best interests of all those involved in the development, manufacturing, testing, and distribution of these products. One of the largest current threats to these devices working safely and effectively is cyberattacks that can wreak havoc on code and device functionality. Preventing these attacks by identifying sources of threats and rooting them out before they can take effect is of the utmost concern.

In this webinar, you will learn just how cyberattacks threaten medical devices and how industry is currently responding to them. We will discuss the many ways of preventing and mitigating the cybersecurity risk, and about the industry best practices that can help your company do the same.

This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.

You should attend this webinar if you are responsible for planning, executing or managing the development or implementation of any system governed by FDA medical device or software regulations, or if you are maintaining or supporting such a system

Webinar Takeaway

This webinar will cover the following key areas:

• Provide an overview of cybersecurity and guidance on device software, including IEC 62304
• Provide an overview of the most common problems faced by industry in terms of medical device security, efficacy, and safety
• Cybersecurity and guidance on device software
• Cybersecurity Plan
• Most common problems faced by the industry in terms of medical device security, efficacy, and safety
• Risk-based Analysis
• Hazard Analysis following ISO14971
• Risk Communication to users
• Required Membership in information sharing groups
• Reporting Requirements and Exceptions
• Provide a set of best practices and industry standards to meet the challenges of cybersecurity and other threats to devices and software
• Q&A

Who Will Benefit

Personnel in the following roles will benefit:

• Medical Device Cybersecurity Professionals
• Medical Device Professionals – IT, SMEs, Quality
• Information Technology Analysts
• Information Technology Developers and Testers
• Software Quality Assurance Professionals
• QC/QA Managers and Analysts
• Analytical Chemists
• Compliance and Audit Managers
• Laboratory Managers
• Automation Analysts
• Manufacturing Specialists and Managers
• Supply Chain Specialists and Managers
• Regulatory Affairs Specialists
• Regulatory Submissions Specialists
• Risk Management Professionals
• Clinical Data Analysts
• Clinical Data Managers
• Clinical Trial Sponsors
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders/Subject Matter Experts
• Business System/Application Testers
• Vendors responsible for software development, testing and maintenance
• Vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance

Description Of The Topic

This webinar will focus on cybersecurity of medical devices, a key concern for those who develop, manufacture, test, and distribute these products. Protecting medical devices from hacking where someone can alter the actual code embedded in the device could result in injury or death to a patient or consumer. A serious threat, it must be dealt with at all levels to make sure the end product being used by a patient or consumer is perfectly safe and delivers the effective treatment required.

This session will provide some insight into current trends in cybersecurity threats to medical devices and how to follow industry best practices to prevent and/or mitigate these threats.

Cybersecurity is a serious concern for medical device safety and effectiveness. Without protection, software running on a medical device could cause severe injury or death to a patient.