25
Feb
2019

2019 Edition of 62304 Training

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What does one need to know about IEC 62304?

In our 3-day 62304 Training course, we flow through the software development lifecycle drawing attention to requirements of the standard as well as related standards and always current FDA expectations from our experience.  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.

About the author

Partner and General Manager, Brian Pate is ISO 1385:2016 Lead Auditor certified for Medical Device Quality Management Systems (MD), and ISO 19011:2018 Management Systems Auditing (AU) and Leading Management Systems Audit Teams (TL). Brian started his medical device career in anesthesia clinical research in 1985 and has since worked both academia and industry including many years with Johnson & Johnson, Baxter Healthcare, and GE Medical. Brian’s roles have included software engineering, systems engineering, quality assurance, and regulatory affairs. Brian has served on multiple AAMI TIR working groups, including TIR32-2008 (Application of ISO 14971 Risk Management to Software; now IEC 80002-1) and TIR45-2012 (Guidance on the use of Agile practices in the development of medical device software) and served as a reviewer for the 2nd edition of TIR45. Brian serves on the AAMI Software Committee and as an AAMI instructor for the software, design controls, and agile methods courses. Brian also is a member of the Underwriters’ Laboratories (UL) Standards Technical Panel for UL1998 (Software in Programmable Components) and or UL5500 (Remote Software Updates).

SoftwareCPR Training Courses

ISO13485:2016 ISO 13485 Internal Audit(or) Training Course (Live, 3-day)

IEC 62304 and other Emerging Standards Impacting Medical Device Software (Live, 3-day)

Being Agile & Yet CompliantISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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