• Duration

    90 minutes

  • Instructor

    Shawnnah Monterrey

  • Program

    SOAR® Training

Course 16: Cybersecurity

This 90-minute course that provides an overview of topics such as: 
  • Broad regulatory requirements related to Cybersecurity
  • Specific requirements from IEC 62304 for Cybersecurity
  • Insights into how to put the regulations, standards, and guidance for Cybersecurity into practice
  • Agile's impact on Cybersecurity
  • The application of Agile in Cybersecurity
All SOAR® Courses award a certificate upon completion.
SOAR® and DIY Regulatory Kit subscribers are awarded SOAR® Certification upon completion of all 15 courses.
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Shawnnah Monterrey

CEO, BeanStock Ventures
Shawnnah Monterrey founded BeanStock Ventures following nearly a 20-year career as a technical leader. Shawnnah was responsible for developing strategies and leading complex global product development programs and functional management of software and software quality assurance departments for both startup and mature organization with emphasis on the development of medical instruments, life science, diagnostics, clinical applications.

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