Medical Device Design Controls 101 – A Practical Crash Course



Medical Device Design Controls 101 – A Practical Crash Course
Date: November 17, 2016
Time: 1:00pm-2:30pm, EST US
Duration: 90 Minutes – Online
Price: $299 – Includes Bonus Handouts!
Course Description:

Design control deficiencies continue to be in the top three FDA Warning Letter findings since 2007. Despite these findings over a long period of time, firms still fail to correct common design control failures. As FDA becomes increasingly frustrated with the level of findings, they have made significant strides to crack down on lapses in design control protocols. If you want to ensure your efforts stand up to any scrutiny, then join us for this comprehensive webinar. By attending, you will learn about robust implementation of a design control process that is both compliant to 21 CFR 820.30 and practical!

Join our interactive online training course where you will learn:

The importance of design planning – including quality planning
Design inputs and design outputs – from needs to requirements to specifications
Design Verification and Validation: learn how to build the right device and build it right
Integration of risk management into the design and development lifecycle
Integration of risk management per EN ISO 14971:2012
Integration of human factors and usability per EN ISO 62366-1:2015
Who Should Attend
This course will be of benefit to anyone involved in the design and development process for medical devices. This includes project managers, engineers, executives leading new product initiatives, regulatory and quality specialists. as well as new product developers.

Instructor Bio
David Amor, MSBE, CQA is a medtech/biotech consultant and mobile health entrepreneur who founded Medgineering, a company focused on remote compliance, regulatory & quality systems consulting for larger companies and start-ups alike. A graduate of the prestigious Innovation Fellows program at the University of Minnesota’s Medical Device Center, David was named a Top 40 Under 40 Medical Device Innovator in 2012 and a 35 Under 35 Entrepreneur in 2015 by MN Biz Magazine. Recently, David co-founded and helped launch Remind Technologies, a Texas based mobile health company developing smartphone based remote medication management system (www.remind-technologies.com). He also is co-inventor on several issued utility patents and co-pioneered a disruptive e-consulting platform for the medtech and pharma industries called QuickConsult (www.myquickconsult.com). Lastly, David also serves as an adjunct professor at St. Cloud State University in Maple Grove, MN where he teaches courses on risk management and design control. The current focal points of his consulting practice are specializing in risk management, design controls, combination products and mHealth.

Ad Reference ID: 661582a03df5e00f

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