62304 and Emerging Software Standards Training Course

Tuesday, Jun 4, 2019 at 8:00 AM to Thursday, Jun 6, 2019 at 4:30 PM EST

10 Buick Street, Boston, MA, 02215, United States

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Course Registration (open until 5/29/19 at midnight eastern time!) Partial Approval - $2,495.00

Course registration for 3 day training in 62304, FDA, and emerging standards for medical device and HealthIT software. Save 24% when purchasing 4 or more registrations. No refunds but substitutions are allowed.

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2. Review and Proceed

Tuesday, Jun 4, 2019 at 8:00 AM to Thursday, Jun 6, 2019 at 4:30 PM EST

TBD, 10 Buick Street, Boston, MA, 02215, United States.

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 2019 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.

Cancellation policy

If training course must be cancelled, all registration fees will be refunded.  SoftwareCPR is not responsible for other costs incurred by registrant.

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.

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