Medical Device Cybertechnology and FDA Compliance

Carolyn Troiano
From: Oct 17, 2022 - To: Dec 31, 2022
Recorded Webinar


This webinar will focus on the 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.

Learning Objectives:-

  • Learn about cyberthreats that are increasing in cyberspace used by people to develop, test, support, and use medical devices with software and Software-as-a-Medical Device (SaaS) products
  • Learn about the challenges and vulnerabilities facing the industry today
  • Learn what FDA is doing to confront the cyber threats and what further work may be done
  • Learn about the potential impact on data, processes, products, and patients based cybertechnology
  • Learn about what to look for when identifying a medical device company to work with on products
  • Learn about industry best practices for countering cyber threats

Areas Covered:-

This webinar will cover the following key areas:-

  • Understand  cybersecurity and guidance on-device software
  • Learn about the most common problems faced by the industry in terms of medical device security, efficacy, and safety
  • Understand the best practices and industry standards to meet the challenges of cybersecurity and other threats to devices and software
  • Learn how safe and effective medical devices are in the best interests of all those involved in developing software for these products, and for those involved in developing medical devices that use the software
  • Gain insight into the IEC 62304 standard as it is applied to medical device software
  • Learn how to apply this standard to your work processes
  • Gain insight into the current industry best practices that will help you with IEC 62304 compliance
  • Q&A


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.

There are many forms of cybersecurity and many remedies for thwarting attempts to penetrate medical device software.  Most of these are based on physical and logical security practices that are becoming best industry practices.

This webinar will detail some of the threats and ways to mitigate them to protect consumers from harm.

This webinar will also focus on IEC 62304. Medical devices can use very complex software applications, and any failure to function properly could lead to the potential injury or death of a consumer or patient.

There is a need to improve overall standards for medical device software to account for this high-risk potential.

The majority of software recalls in the 1990s were due to software defects that were a result of software being upgraded.

There is a need to restructure medical device software development processes, and adopting IEC 62304 provides a standard for a design that is accepted in the United States (US) and European Union (EU).

IEC 62304 is a risk-based approach to compliance that ensures the standards followed are appropriate for their potential assessed risk.

IEC 62304 is a lifecycle approach that defines the activities and tasks required to ensure software for medical devices will be safe and reliable.

Applying IEC 62304 will reduce your overall rate of software failure and improve your bottom line.

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 the industry is currently responding to them. We will discuss the many ways of preventing and mitigating the cybersecurity risk, and 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 devices, biological, animal health, and tobacco. Applicable functions 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.

Who Should Attend:-

This webinar is intended for those involved in planning, executing, and support of computer system validation activities, working in the FDA-regulated industries, including pharmaceutical, medical devices, biologics, tobacco, and tobacco-related products (e-liquids, e-cigarettes, pouch tobacco, cigars, etc.).  Applicable functions include research and development, manufacturing, Quality Control, distribution, clinical testing and management, sample labeling, adverse events management, and post-marketing surveillance.

  • 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

Training Options

Error Conference Exists In Wish-list.

Congrats Conference Added In Wish-list.





Tokyo is the capital of Japan.

* Or more than 6 attendee call us at +1-(833) 568-8254 or mail us at

* For Cheque and ACH payment call us at +1-(833) 568-8254 or mail us at

* Click to download the Order Form