This course will provide the background related to IEC 62304 compliance and medical devices.  These devices may include or incorporate software that must function properly.  Manufacturers must have the processes and procedures in place to ensure they will meet all requirements and deliver benefit to the patient or consumer.  There are also software companies that create applications that work in conjunction with medical devices, and these companies must understand FDA compliance.  In addition, e-cigarette and e-liquid companies should be interested in IEC 62304 compliance, as their devices typically are considered to be medical devices and are under FDA regulation, based on the “Deeming Rule” that was enacted in 2016.

Why Should You Attend:

You should attend this webinar if you are implementing, managing, using or auditing computer systems and/or software involved in medical devices.  There may be software used that is in and of itself a medical device – Software as a Medical Device (SaaMD), or software used in conjunction with a physical medical device.  Also, software may be used in the manufacture, testing and supply chain activities related to a medical device, and must be validated according to FDA requirements for Computer System Validation (CSV).  You will learn about the standards that are driving better compliance and quality in the medical device hardware and software industries.

Course Outline:

• Providing 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
• This session will provide insight into the IEC 62304 standard as it is applied to medical device software
• You will learn how to apply this standard to your own work processes
• You will also gain insight into the current industry best practices that will help you with IEC 62304 compliance

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

This webinar is intended for those working in the medical device industry, or any related industry.  For example, the e-cigarette and e-liquid industries may incorporate medical devices into their products.  Similarly, software companies may deliver products incorporated into medical devices, or may sell software as a medical device (SaaS).

• Regulatory Affairs Professionals
• Compliance and Audit Professionals
• Quality Assurance Professionals
• R&D Professionals
• Clinical Data Management Professionals
• Laboratory Professionals
• Manufacturing Professionals
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders/Subject Matter Experts
• Business System/Application Testers

This webinar will also benefit any consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.

Topic Background:

This webinar will focus on medical devices, IEC 62304, and what is required for compliance.

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.