Request corporate pricing!
Choose your plan
Starter Software Regulatory Kit
FREE
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
SOAR® Training
$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
DHF Templates
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
-
Continuously updated
-
Designed by medical software experts
Corporate Pricing
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
Peter Holmes