FDA medical device cybersecurity

 

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 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 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. 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 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 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
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