Welcome to SOAR®

#Software | #Online | #Agile | #Regulatory

Software Online Agile Regulatory (SOAR®) is fundamentals training for today's medical software engineer.

Level Up Your Medical Device Expertise.

Our school is developed by experts with 20+ years of experience in medical device. We teach you how to get your innovative medical device to market faster.
  • 24 hours of course content
  • Easily digestible 90-minute courses
  • Certificate of Completion for each course
  • SOAR® Certification awarded for completing every course

24 Hours

of on-demand course content

Bundle SOAR® with DHF Templates in our DIY Software Regulatory Kits!

SOAR® is a 16-course on-demand training program that has been designed to enable software engineers to satisfy regulations while maintaining their agility.

 01

Align Quality and Software

Efficiently integrate Agile into the Regulatory landscape 

 02

Advanced Regulatory Knowledge for Real-World Application

Establish regulatory background and review requirements

 03

Create Confidence

Meet aggressive product launches and increase ease in passing internal and external audits and inspections

Learn from our experts.

BeanStock Ventures has over 20 years of experience in software development for the healthcare and life science space and is 1 of 7 FDA-accredited Third Party Review Organizations globally.

We provide software development and regulatory compliance products and services to minimize complexity, reduce cost, and reduce time to market of innovative medical devices.

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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Your getaway for online digital health learning.