Designing Medical Devices for high reliability & safety: Hands-on Workshop – 2-day In-person- LVC

Location: Attend Live Webinar
Dates: 14th-15th Jan-2015 : 9:00 AM PST
Duration : 720 Mins

Speaker: Dev Raheja , MDS

Dev Raheja, MS,CSP, is an international Risk Management and Quality Assurance consultant for Healthcare, medical device, and aerospace industry for over 25 years. He applies evidence base safety techniques from a variety of industries to healthcare. He is a trainer, author of the books Safer Hospital Care, Assurance Technologies Principles and Practices, and Design for Reliability. He shows clients how to come up with elegant solutions using creativity and innovation. Being a true international consultant, he has conducted training in several countries including Sweden, Australia, Japan, Germany, UK, Singapore, Taiwan, South Africa, Finland, and Brazil. He helped a major Midwest company from going out of business to becoming a world leader by eliminating safety mishaps. Prior to becoming  a consultant in 1982 he worked at GE healthcare as Supervisor of Quality Assurance and Manager of Manufacturing, and at Booz-Allen &Hamilton as Risk Management consultant for nuclear and mass transportation industry.

Course Description:

According to FDA data, typically between 13 and 75 devices are recalled each day, though the majority of those recalls are either Class II or Class III recalls. Therefore dangers to patients from medical devices lurk in large numbers. These dangers are present in many devices such as: MRI equipment, CT scanners, nuclear medicine equipment, defibrillators, infusion pumps, ventilators patient monitoring systems, electronic health record computers. There are also dangers in medical accessories such as: interface connectors, surgical trays, syringes and valves, IV tubes that transport blood, catheters. While medical devices are obviously designed to benefit patients, they can also cause harm. In 2013, the US Food and Drug Administration (FDA) recalled more than 1200 medical devices—the highest number ever recalled in a single year. Since 2004, 86% of all recalls have been Class II recalls, while 7% have been Class III and 6% have been Class I. One in three FDA device recalls was due to software errors.

Reasons to attend:

This 2-day workshop will provide the attendees with best practices for designing medical devices that are highly reliable, ultra-safe, at lower life cycle costs. Several case histories will be covered from the presenter’s experience of over 30 years with companies such as GE Healthcare, Siemens Medical Systems, and Johnson & Johnson. It is recommended that the entire new product development attend including software engineers and manufacturing engineers, because workshops are more powerful when cross functional disciplines are participating. This workshop is designed for attendees at all levels including senior management. Everyone is responsible in some way for high reliability and safety for protecting patients.

AGENDA:

Who can Benefit from this Program

• All engineers and managers
• Regulatory affairs professionals
• Marketing Managers
• Service managers
• Project Managers and engineers
• Vice presidents of Engineering and Software Development
• Quality Assurance staff
• IT professionals looking to make the design process efficient.

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To Enroll for This Program today  please click hear

Thank you & Regards,

Kevin Roberts,

Training Manager,

kevin.roberts@complianzworld.com

Call us at this Toll Free number: +1-866-978-0800

http://www.complianzworld.com