2020 SoftwareCPR 62304 and Emerging Software Standards Training Course - Sunnyvale, CA

Tue, February 04 2020, 11:30 AM - Thu, February 06 2020, 7:00 PM [PST]

1085 E El Camino Real, Sunnyvale, CA, 94087, United States

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General Registration through January 22, 2020 PARTIAL APPROVAL - $2,595.00

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.

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Tue, February 04 2020, 11:30 AM - Thu, February 06 2020, 7:00 PM [PST]

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:

  • Regulatory Background – US FDA, EU MDR
  • Types of Software – Medical Device, Health-IT, General Wellness, Cloud Services, Mobile Medical Apps, Personal Health Software
  • Design Controls / 62304 / 82304 in the context of a system
  • Overview of related standards and guidance 60601-PEMS, 82304 Health Software, 80002-1 Risk Management Background and Structure, Cybersecurity 80001-1 IT Networks, 62366 Usability, Privacy HIPAA and EU
  • Use of Standards
  • 62304 Software Safety Classifications / Contrast with FDA LOC
  • Software Development Process Planning / Agile Methods Planning
  • SOUP (open source, commercial), Legacy Software
  • "Real" Design Input / Requirements / Formative usability
  • Architecture and Detailed Design
  • Implementation, coding, unit verification
  • Integration and integration testing
  • Software Risk Management
  • Probability and Severity related to software
  • Harms, Hazards, Identifying Causes and Risk Controls
  • Process as Risk Control
  • Managing Risk after release
  • Document Hierarchies and Traceability / Electronic records / Data Models
  • Maintenance Process / Problem Issue and Defect Management
  • Validation / 82304 / Summative usability
  • Release, Configuration Management / Rapid release
  • Networked Devices / Cybersecurity / 80001-x
  • SaMD / Design Review

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/

Crisis Prevention and Recovery LLC (SoftwareCPR)

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.

Contact the Organizer View other events

Brian Pate
Partner & General Manager

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.

https://www.softwarecpr.com

About Brian Pate

Partner & General Manager