DIY Software Regulatory Kit
Required. Affordable. Easy to use.
Streamline your FDA or EU submission with our DIY Software Regulatory Kit.
This do-it-yourself kit includes associated design templates and training that provides you with guidance and best practices to help you complete your SiMD/SaMD regulatory technical submission.
Low Cost Access
High Quality Templates
Save over $200k and 18 months in FDA preparation.
What's included in our DIY Software Regulatory Kit?
Included in our Software Regulatory Kit bundle is a 12-month subscription to SOAR® Training. 16, 90-minute courses - 24 hours of on-demand training.
Monthly Q&A Sessions
Exclusive to our Software Regulatory Kit Bundle. Participate in monthly live Q&A sessions with industry experts in software to assist your FDA submission.
Full DHF Templates
Our Software Regulatory Kit Bundle includes access to all 24 design templates. Required by the FDA and compliant with FDA guidance's and EU international standards.
Peace of Mind
Eliminate any guesswork in preparing your submission or technical file. Have confidence as our templates and feedback from industry experts lead you to a successful FDA submission.
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