Course 02: IEC 62304 Overview

This 90-minute course covers:
  • The scope and structure of IEC 62304
  • Patterns for what IEC 62304 requires
  • How required elements of IEC 62304 can be addressed within an Agile development model
This course is included in our Starter Software Regulatory Kit. 
All SOAR® Courses award a certificate upon completion.
SOAR® and DIY Regulatory Kit subscribers are awarded a SOAR® Certification upon completion of all courses.
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Kelly Weyrauch

Owner, Agile Quality Systems & a Principal Author of AAMI
As one of the principal authors of AAMI TIR45 Guidance on the Use of AGILE Practices in the Development of Medical Devices Software, Kelly has worked with the FDA and industry leaders on the application of AGILE practices to the medical device world.

Key Standards & Guidance

All of our courses satisfy FDA standards and requirements
  • 21 Code of Federal Regulations – Part 11 Electronic Records; Electronic Signatures
  • 21 Code of Federal Regulations – Part 820 Quality System Regulation for Medical Devices and In Vitro Diagnostic Products
  • AAMI TIR45:2012 - Guidance on the Use of AGILE Practices in the Development of Medical Device Software
  • AAMI/ISO 80002-2:2017 - Medical device software— Part 2: Validation of software for medical device quality systems
  • AAMI/ISO TIR24971:2020 - Medical devices — Guidance on the application of ISO 14971
  • ANSI/AAMI HE75:2009 (R2018) Human Factors Engineering - Design Of Medical Devices
  • FDA Content of Premarket Submissions for Software Contained in Medical Devices
  • FDA Design Controls Guidance for Medical Device Manufacturers
  • FDA General Principles of Software Validation
  • FDA Guidance Applying Human Factors and Usability Engineering to Medical Devices​
  • FDA Off-The-Shelf Software Use in Medical Devices
  • IEC 60601-1 Medical electrical equipment
  • IEC 62304 – Medical Device Software – Software Life Cycle Processes
  • IEC 62366-1:2015 Medical Devices - Part 1: Application Of Usability Engineering To Medical Devices
  • IEC 82304 – Health Software - Part 1: General requirements for product safety
  • IEC/TR 80002-1:2009 - Medical device software – Part 1: Guidance on the application of ISO 14971 to medical device software
  • IEC/TR 80002-3:2014 - Medical device software -- Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
  • IEEE 610.12-1990 - IEEE Standard Glossary of Software Engineering Terminology
  • ISO 9001:2015 Quality management systems — Requirements
  • ISO 13485:2016 Medical Devices – Quality Management Systems
  • ISO 14971:2019 - Medical devices – Application of risk management to medical devices
  • ISO/IEC/IEEE 29148-2018 - Systems and software engineering -- Life cycle processes -- Requirements engineering
  • REGULATION (EU) 2017/745 – Medical Device Regulation
  • REGULATION (EU) 2017/746 – In Vitro Diagnostic Regulation

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