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Choose your plan
We offer several packages with easy, affordable monthly subscription options that can save you thousands in regulatory costs.
Starter Software Regulatory Kit
Create a free account to access free courses, starter templates, and our community resource center.
2 FREE SOAR® courses
10+ Starter DHF templates
DIY Software Regulatory Kit
$999/mo for 12 months
Save $200k in regulatory costs and 18 months in preparation for your FDA submission. Be confident in your submission and get your device to market faster.
24 premium DHF templates
12 month SOAR® subscription
Monthly Live Q&A sessions
Flexible payment options
SOAR® Training Certification
$295/mo for 12 months
Software Online Agile Regulatory (SOAR®) Fundamentals Training for today's medical software engineer.
15 full courses
90 minutes each
24 hours of total training
Subscribe for full access or purchase individual courses
SOAR® Training certificate for each completed course
SOAR® Training Certification with subscription
Design History Files (DHFs) are required by the FDA for your device's submission. Remove any guesswork and have confidence by purchase on-demand templates to fit your regulatory needs.
24 ready-to-use DHF templates
Complies with FDA guidances and international standards
Designed by medical software experts
Looking to enroll your entire development team? Contact us to learn more about corporate pricing options.
Key Standards & Guidance
All of our courses and premium templates 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
How our content helps developers succeed
Read the testimonials of our community members and discover how our course helped them achieve their goals.
“The Software Architecture template was a massive time-saver for us. The document is comprehensive, clearly organized, and gave my team the guidance necessary to customize our document by emulating the original content structure.”
COO, Barefoot Solutions