DIY QMS Regulatory Kit
Required. Affordable. Easy to use.
Streamline your quality system compliance with our prebuilt DIY QMS Kit.
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DIY QMS Regulatory Kit for Medical Device Quality Systems
Building a quality management system (QMS) from the ground up can take significant time and resources, especially for growing medical device teams. A QMS is needed throughout the medical device lifecycle, from design and development through regulatory submission, commercialization, and post-market activities. Implementing your QMS early helps ensure critical activities such as design controls, risk management, supplier controls, and document control are established as your product is developed.
At Grassroots Dx, we developed our DIY QMS Regulatory Kit for digital health startups, medical device manufacturers, and IVD teams that need to establish a new QMS or remediate existing processes.
Our kit combines customizable ISO 13485 based QMS templates and SOPs, training, and expert guidance to support preparation for applicable FDA and European regulatory requirements. Rather than beginning with blank process documents or relying on eQMS software to define your processes, teams receive a structured foundation they can adapt to their organization, products, responsibilities, and quality processes.
For teams considering an eQMS, establishing this foundation first can also help you understand how your quality system actually works, where it will need to scale, and what functionality you need before investing in a software platform or long-term subscription. Your QMS should define your processes; the software you ultimately choose should support them.
At Grassroots Dx, we developed our DIY QMS Regulatory Kit for digital health startups, medical device manufacturers, and IVD teams that need to establish a new QMS or remediate existing processes.
Our kit combines customizable ISO 13485 based QMS templates and SOPs, training, and expert guidance to support preparation for applicable FDA and European regulatory requirements. Rather than beginning with blank process documents or relying on eQMS software to define your processes, teams receive a structured foundation they can adapt to their organization, products, responsibilities, and quality processes.
For teams considering an eQMS, establishing this foundation first can also help you understand how your quality system actually works, where it will need to scale, and what functionality you need before investing in a software platform or long-term subscription. Your QMS should define your processes; the software you ultimately choose should support them.
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 experienced medical device professionals—designed to help you achieve compliance and accelerate your FDA or EU MDR submission.
Build or Remediate Your QMS With a Structured Foundation
A well designed quality management system defines how an organization manages quality responsibilities and applicable regulatory requirements. It also establishes the processes your team follows throughout the product lifecycle, from design and development through manufacturing, commercialization, and post-market activities.
When an existing quality system has gaps, remediation involves reviewing current processes and addressing areas that require improvement. Our quality management system template resources provide teams with a practical starting point while allowing processes to be customized to their specific operations.
We designed the kit around ISO 13485:2016 and applicable FDA Quality Management System Regulation (QMSR) requirements under 21 CFR Part 820. The included ISO 13485 templates help teams establish a process framework without having to develop every aspect independently. Whether you are establishing your first QMS, preparing for design controls, or strengthening an existing quality system, the kit gives you a framework that can grow with your organization.
When an existing quality system has gaps, remediation involves reviewing current processes and addressing areas that require improvement. Our quality management system template resources provide teams with a practical starting point while allowing processes to be customized to their specific operations.
We designed the kit around ISO 13485:2016 and applicable FDA Quality Management System Regulation (QMSR) requirements under 21 CFR Part 820. The included ISO 13485 templates help teams establish a process framework without having to develop every aspect independently. Whether you are establishing your first QMS, preparing for design controls, or strengthening an existing quality system, the kit gives you a framework that can grow with your organization.
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What Is Included in Our DIY QMS Regulatory Kit?
Our kit brings process SOPs, education, and access to expert guidance together in one resource. Based on the current kit information, it includes:
A quality manual template provides a foundation for organizing the quality system, while the broader QMS template collection helps teams define and document the processes that make up their quality system, rather than starting each procedure, form, and record from scratch.
The templates are designed to be customized to reflect how your organization actually operates, giving you a practical starting point without locking you into a one size fits all quality system.
- Customizable QMS SOPs, templates, forms, and supporting documentation based on ISO 13485:2016 and applicable FDA QMSR requirements under 21 CFR Part 820
- One live Q and A session with a quality and regulatory expert
- Processes intended to support FDA and European regulatory preparation
A quality manual template provides a foundation for organizing the quality system, while the broader QMS template collection helps teams define and document the processes that make up their quality system, rather than starting each procedure, form, and record from scratch.
The templates are designed to be customized to reflect how your organization actually operates, giving you a practical starting point without locking you into a one size fits all quality system.
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
Support for FDA and ISO 13485 Quality System Requirements
Medical device quality systems must account for applicable regulatory standards and requirements. Our kit is built around ISO 13485:2016 and applicable FDA Quality Management System Regulation (QMSR) requirements under 21 CFR Part 820, providing a practical framework that teams can adapt to their organization and products.
For a team considering an FDA QSR compliance kit, templates can provide an organized framework for getting started. But a compliant QMS is more than a collection of SOPs. Your procedures need to reflect how your organization actually operates, and your team needs to understand and consistently follow those processes.
Our templates provide the starting framework, while SOAR® training and expert guidance help your team understand how to customize and implement the system. Effective quality systems for medical devices should reflect how quality activities are carried out rather than serve only as a collection of completed process documents.
For a team considering an FDA QSR compliance kit, templates can provide an organized framework for getting started. But a compliant QMS is more than a collection of SOPs. Your procedures need to reflect how your organization actually operates, and your team needs to understand and consistently follow those processes.
Our templates provide the starting framework, while SOAR® training and expert guidance help your team understand how to customize and implement the system. Effective quality systems for medical devices should reflect how quality activities are carried out rather than serve only as a collection of completed process documents.
Understand the Potential Time and Cost Savings
Developing a quality system process without an established framework can require substantial internal effort and outside resources. Teams may spend months researching requirements, developing SOPs and forms, obtaining outside consulting support, and implementing processes that have already been established successfully across the medical device industry.
The DIY QMS Regulatory Kit gives your team a proven starting process framework rather than asking you to build your quality system from a blank page. Grassroots Dx estimates that this approach can save teams over $150,000 and up to 12 months in QMS development and FDA preparation.
Your actual time and cost savings will depend on your organization, product, existing documentation and processes, regulatory pathway, and the level of customization or remediation required.
The DIY QMS Regulatory Kit gives your team a proven starting process framework rather than asking you to build your quality system from a blank page. Grassroots Dx estimates that this approach can save teams over $150,000 and up to 12 months in QMS development and FDA preparation.
Your actual time and cost savings will depend on your organization, product, existing documentation and processes, regulatory pathway, and the level of customization or remediation required.
Give Your Team a More Practical Starting Point
Our DIY approach is intended for digital health startups, medical device manufacturers and IVD teams that want a structured way to establish or improve their QMS while retaining responsibility for adapting the process to fit the needs of their organization. Templates reduce the need to define each process from scratch, while training provides additional context for teams working through quality system requirements.
With the DIY QMS Regulatory Kit, Grassroots Dx brings together ISO 13485 based QMS templates and SOPs, on-demand training, and live expert guidance to help your team build, customize, and implement a quality system that supports your organization from product development through post-market activities.
Whether you are putting design controls in place for the first time, preparing for commercialization, remediating an existing QMS, or establishing your quality framework before moving to an eQMS platform, you can start with a structured system and adapt it as your company grows.
Explore what's included in the DIY QMS Regulatory Kit and choose the option that suits your team.
With the DIY QMS Regulatory Kit, Grassroots Dx brings together ISO 13485 based QMS templates and SOPs, on-demand training, and live expert guidance to help your team build, customize, and implement a quality system that supports your organization from product development through post-market activities.
Whether you are putting design controls in place for the first time, preparing for commercialization, remediating an existing QMS, or establishing your quality framework before moving to an eQMS platform, you can start with a structured system and adapt it as your company grows.
Explore what's included in the DIY QMS Regulatory Kit and choose the option that suits your team.
Frequently asked questions
Who is the DIY QMS Regulatory Kit designed for?
Our kit is designed for digital health startups, medical device manufacturers, and IVD innovators establishing a new quality management system or remediating existing processes. It can support companies throughout the product lifecycle, from teams establishing design controls during development to companies preparing for commercialization or maintaining their post-market quality system.
What should teams look for in a Quality Manual Template?
A quality manual template should provide a structured starting point for documenting a medical device organization's quality system. Our DIY QMS Regulatory Kit includes a quality manual and customizable QMS templates designed to support ISO 13485 and applicable FDA QMSR requirements under 21 CFR Part 820.
Can the QMS Template be customized?
Yes. Our QMS template resources are described as customizable, allowing teams to adapt the process to their organization, products, responsibilities, and actual quality processes rather than treating templates as finished company specific procedures.
What do the Quality Management System Template resources support?
Our quality management system template resources provide a structured foundation for developing QMS processes. The kit helps teams establish and document quality processes across the medical device lifecycle, including design and development, quality management, and post-market activities. Teams still need to adapt and implement their processes according to their actual operations and applicable requirements.
Are ISO 13485 resources included?
Yes. The kit includes customizable ISO 13485 templates and is built around ISO 13485:2016 requirements.
Does the kit address FDA quality system requirements?
Yes. Our DIY QMS Regulatory Kit addresses applicable FDA Quality Management System Regulation (QMSR) requirements under 21 CFR Part 820. For teams searching for an FDA QSR compliance kit, these resources provide templates intended to support applicable FDA quality system requirements.
Do I need an eQMS to implement a medical device QMS?
Not necessarily. An eQMS is software used to help manage and operate quality system processes, but your organization still needs to define those processes. For many early stage companies, establishing the QMS framework first can help the team understand its processes, responsibilities, and future scaling needs before selecting an eQMS platform. The Grassroots Dx DIY QMS Regulatory Kit provides the underlying templates and framework that can be implemented by your team and later transitioned into an eQMS as your organization grows.
Is the kit relevant to medical device documentation?
Yes. Our kit supports quality system documentation for medical devices and is specifically designed for digital health startups, medical device manufacturers and IVD innovators setting up or remediating a QMS.
Does the kit include expert support?
Our DIY QMS Regulatory Kit includes one live Q&A session with a quality and regulatory expert.