3hr Virtual Seminar On Designing Medical Devices For Patient Safety

Medical devices represent a significant sector of the U.S. healthcare industry, with annual sales exceeding $13 billion. These devices, including pacemakers, cardiac defibrillators, infusion pumps, and neural stimulators, have unacceptably high failure rates. Missing safety requirements in the product specification are often the source of harm to patients.

For next-generation devices, which are much more complex, we must include robustness requirements in the specifications through hazard analyses during the concept stage. FDA approval hinges on demonstrated safety and the reliability of the safeguards. Including safety requirements early reduces the time to market.

Attend this webinar to learn how you can design medical devices that ensure patient safety. We will also review hazard analysis techniques and safety design techniques for devices, including next-generation ones.

Areas Covered in the Seminar:

- Dangers to patients from medical devices.
- Inherent technology dangers to patients.
- Equipment software dangers that harm patients.
- Dangers from sneak conditions.
- User interface dangers.
- Hazard analysis techniques to predict harm.
- Preliminary Hazard Analysis
- Subsystem Hazard Analysis
- System Hazard Analysis
- Usability Hazard Analysis
- Safety design techniques to mitigate harm.
- New paradigms for efficient design improvements.
- Writing safety specifications for robustness.
- Design verification and validation for safety.

Who Will Benefit:

This webinar will provide valuable assistance to all Medical Device companies/ manufacturing sites. Those that would benefit most would be:

- R&D, Scientists
- Engineers
- Product Management, Product development
- Safety
- Regulatory
- Purchasing & Production
- Quality Assurance Managers
- Sales and Marketing
- Suppliers

Instructor Profile:

A respected and sought out expert on medical device and hospital care safety, author Dev Raheja draws on his 25 years of experience as a risk management and quality assurance consultant to provide medical device stakeholders with a systematic way to learn the science of safety and reliability. He uses evidence-based safety theories and tools taken from the aerospace, nuclear, medical, and chemical industries to identify the combination of root causes that result in an adverse event. He applies analytical tools that can effectively measure efficiency, establish evidence between Lean strategies and patient satisfaction.

His focus is on using various types of innovations to encourage a culture conducive to high return on investment. He is the author of the books Assurance Technologies principles and Practices, and Safer Hospital Care. He has served as Associate Professor for the PhD degree in Reliability Engineering at University of Maryland during 1994-99.