Medical Device Software Cybersecurity and IEC 62304 Compliance

Carolyn Troiano
Instructor:
Carolyn Troiano
Date:
Monday, December 20, 2021
Time:
10:00 AM PST | 01:00 PM EST
Duration:
90 Minutes

More Trainings by this Expert   Product Id : 504186

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$190 Recorded
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Overview:

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 in 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 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 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 you should 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.

Areas Covered in the Session:

  • Understand cybersecurity and guidance on device software
  • Learn about the most common problems faced by 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 is in the best interests of all those involved in developing software for these products, and for those involved in developing medical devices that use software
  • Gain insight into the IEC 62304 standard as it is applied to medical device software
  • Learn how to apply this standard to your own work processes
  • Gain insight into the current industry best practices that will help you with IEC 62304 compliance

Who Will Benefit:
  • Medical Device manufacturing, Testing, Packaging and Distribution companies
  • In some cases, the medical device software will be provided by a software development firm vs. the medical device company itself
  • In some cases, the medical device will deliver a drug to a patient, and so those working in the pharmaceutical and/or biotechnology industries may have some interest in this topic


Speaker Profile
Carolyn (McKillop) Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.

During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA's electronic record/electronic signature regulation.


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