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.
Why Should You Attend
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 implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system.
- 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.
Who will Benefit
Professionals in the following industries may also benefit from the content:
- Medical Device
- Tobacco and Related (Vapor, e-Cigarette, Cigar, etc.)
Any other FDA-regulated industry, plus any Life Science Consulting or Contracting firm
Industries who can attend
This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.