Our motto is

#Expertise. | #Confidence. | #Excellence. | #Compliance.

Designed for today's medical software engineer, we provide in-depth regulatory resources to strengthen your development teams, stay informed, and help you achieve your software medical device development goals.

Ready to level up your development skills?

We offer a Basic Starter Software Regulatory Kit for all our community members

Save more and get to market faster with our DIY Software Regulatory Kits.

12 Month SOAR® Training Subscription

One year full on-demand access to all 16 courses.

24 Full Design History File (DHF) Templates

Walkthrough templates to complete the required technical specifications for your product's regulatory submission.

Live Q&A's

Receive monthly support and feedback with our industry experts along with your peers.

Key Areas of Content

  • Pre-market submissions for medical devices with embedded software
  • General principals of software validation
  • Software as a Medical Device (SaMD)
  • Clinical decision support software
  • Medical device data systems (MDDS)
  • EU Medical Device Regulation IEC/ISO 13485 
  • EU Medical Device Regulation 14971
  • EU Medical Device Regulation 62304
  • EU Medical Device Regulation 62366

24 Hours of Training

on-demand, with easily renewable subscriptions

Device & Safety Classifications our content satisfies

FDA Device Classification

I, II, & III

IEC 62304 Software Safety Class

A, B, & C

US FDA SaMD Risk Categorization Framework 

I, II, III, & IV

FDA Medical Device Software Level of Concern

Minor, Moderate, & Major

EU MDR Classification for Software as Medical Device

I, II, & III

US FDA Documentation Level 

Basic & Enhanced
"As new and novel products are entering the healthcare space, we found a need to assist in the alignment of regulation and standards to align with the way modern engineers actually do their work. We designed SOAR® Fundamentals Training to start bridging the two areas and foster collaboration."
Shawnnah Monterrey
CEO of BeanStock Ventures

20+

Years of experience

We help you reach your professional goals 

We are industry experts with 20+ years of experience in medical device and we strive to bring innovative software medical devices to market faster. Stay current with:
  • Industry trends and updates
  • Comprehensive courses
  • Step-by-step guidance
  • Regulatory updates

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Your getaway for online digital health learning.