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 FREE Starter Software Regulatory Kits for all 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


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