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Tuesday, 4 February 2020 8:30 AM - Thursday, 6 February 2020 4:00 PM PST
1085 E El Camino Real, Sunnyvale, CA, 94087, United States
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This is the general registration that can be purchased at any time. Largest volume discount available with this ticket (4 or more get $450/person discount through Jan 22, 2020). No other discounts can be combined. Refundable (minus credit card fees) through October 31, 2019. Substitutions allowed.
The Domain Hotel, 1085 E El Camino Real, Sunnyvale, CA, 94087, United States.
Course start 8:30 am PT each day and ends at 5:00 pm PT. Lunch is provided. Course will end at 4:00 pm PT on 3rd day.
This course will cover the entire software development lifecycle drawing attention to requirements of the 62304 standard as well as related standards and always current FDA expectations. The topics we plan to cover in our 2020 course are below.
Topics:
One reason for the popularity of our course is our background and experience with many, many examples of approaches no matter your SDLC, type of software, or organizational structure. Beyond the regulations and standards, our approach is to educate on the intent and current expectations so that the participants are able to make informed decisions in the future. Learn more at our 62304 Training page https://www.softwarecpr.com/training/
https://www.softwarecpr.com
SoftwareCPR® provides full service regulatory compliance and premarket submissions support for Medical Device Manufacturers including quality systems development, risk management - including for Health IT and Standalone Software, Human Factors and usability engineering, as well as hands-on validation services for Pharmaceutical and Medical Device companies. We also have extensive experience related to FDA enforcement action representation and negotiation and have served as expert witnesses.
Brian was a medical device software engineer and product designer for over 20 years and has now been a partner with SoftwareCPR® for 14 years. He is the lead instructor for the AAMI/FDA course on Software Regulation and has taught the course at FDA to FDA Reviewers and other staff. Brian served on the TIR working groups that created the AAMI TIR45 Effective Use of Agile Methods and TIR32 (IEC 80002-1) Software Risk Management. Brian is also a member of the UL Standards Technical Panel 5500, Remote Software Updates.
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