DIY QMS Regulatory Kit
Required. Affordable. Easy to use.
Streamline your quality system compliance with our prebuilt DIY QMS Kit.
Save over $150k and 12 months in FDA preparation.
What's included in our DIY QMS Regulatory Kit?
Training
Included in our Cybersecurity Regulatory Kit bundle is a 12-month subscription to SOAR® Training. 1, 1 30-minute course of on-demand training.
1 Q&A Session
Exclusive to our DIY QMS Kit: Includes one live Q&A session with a quality and regulatory expert to guide your quality system setup and help prepare for FDA or EU MDR submission.
Full QMS Templates
Our DIY QMS Kit includes all the essential templates required for ISO 13485 compliance and FDA QSR, designed to support FDA and EU MDR submissions with confidence.
Peace of Mind
Eliminate the guesswork in building your quality system. Gain confidence with proven templates and expert feedback from FDA-accredited professionals—designed to help you achieve compliance and accelerate your FDA or EU MDR 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