subject: Designing Medical Devices for Patient Safety - Webinar By ComplianceOnline [print this page] Designing Medical Devices for Patient Safety - Webinar By ComplianceOnline
Why Should You Attend:
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.
This training will outline practical steps to design medical devices that ensure patient safety. Hazard analysis techniques and safety design techniques for devices, including next-generation devices, will be reviewed.
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, authorDev 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.
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