$395.00 for One Access Line Registration
$795.00 for Multiple Access Line Registration – Maximum 10 Access Lines
This course is forecasted for 90 minutes including the presentation and Q&A.
Increasing regulatory requirements and restrictions in the medical device industry, particularly in the US, remain persistent as manufacturers are under greater pressure for continuous growth and innovation. New product development (NPD) teams are tasked with the unique challenge of designing and developing next generation medical devices while also remaining in compliance with these regulations. In order to remain competitive in an evolving regulatory environment, many device companies have begun to reassess current NPD policies and procedures to implement new methodologies that will demonstrate compliance to design control and design validation standards.
In this webinar, we will explore effective approaches for and provide insights on the following:
Design inputs
Human Factors & Usability
Unique Device Identification (UDI)
Risk management
Design validation; adequate sample populations and methods
Reference Guidance and Standards
Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:
New Product Development
Engineering NPD
Product Development
SPEAKER BIOGRAPHIES:
Ted is an established inventor with over 50 US patent and multiple foreign patents. Prior to founding Gilero in 2002, Ted held various design engineering and product development team leadership roles with Bionix Medical Technologies and Alaris Medical Systems (now CareFusion BD). Ted’s device development experience is wide ranging, however he has noted expertise in drug access and delivery systems, infection control, ophthalmology, and urology products. These experiences have led to multiple new product introductions and industry recognitions, including being named Medical Device & Diagnostic Industry magazine’s 100 Notable in 2004 and Medical Design Excellence Awards in 2002 and 2014.
Kristin’s engineering background features a strong, technical foundation, with previous roles in manufacturing facilities across several industries. Kristin began her professional career at Honeywell supporting the automotive industry, where she was certified as a Six Sigma Greenbelt, and underwent Six Sigma Blackbelt and Design for Six Sigma training. Kristin then transitioned into the medical device industry and held various roles in quality engineering and new product development at Boston Scientific’s North America R&D headquarters.
Ed designs medical devices that are both highly manufacturable and usable. His drive for human factors and manufacturability in every device started at Becton Dickinson, where he held roles in research, manufacturing, design and program management. As a Director of Design at EG-GILERO, Ed loves helping clients bring lifesaving products from sketch to market with his unique blend of engineering expertise, product design acumen, and entrepreneurial vigor. He is an advocate for the end user of the product and incorporates human factors, heuristics, and formative studies into every design process. His work ranges from passive safety injection devices to advanced drug delivery and continuous biosensors. Ed obtained a Bachelor of Science in Mechanical Engineering from Rensselaer Polytechnic Institute and a Masters in Product Design from Stanford University.
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