QMS toolkits for software as a medical device (SaMD)
A complete resource for SaMD startups to build a quality system and comply with ISO 13485 and 21 CFR 820
Build your QMS and get to market faster
Are you a startup in need of creating a quality system and unsure of where to start? We created the QMS Toolkits to help early-stage SaMD companies understand quality management, build a quality management system, and meet compliance regulations more quickly and cost-effectively.
Our toolkits are designed to scale with you through the entire product lifecycle, from pre-market to post-market. Whether you are in the early stages of design or preparing to go to market, our toolkits can help you at any point of the development process.
Created by medtech professionals, simplified for you
User-friendly toolkits
We make quality management easy with customizable templates and straightforward instructions.
30+
work with
Tailored to startups
We help small teams make big impact. Build your QMS quickly and cost-effectively.
< 4 weeks*
Industry experience
We're a team of medtech professionals with deep experience in crafting agile development processes and quality systems.
100+
What's included in the QMS toolkits?
Each toolkit contains everything you will need to build a QMS for software as a medical device products and comply with ISO 13485 and 21 CFR 820.
digital access + downloadable templates
Pre-market Toolkit
If you're creating a QMS from scratch, this toolkit is for you. Build the foundation of your QMS to align with product design and development stages. This will provide everything you need to prepare your regulatory submission.
Toolkit Contents:
Quality System Manual
Document and Data Control
Control of Records
Design & Development
Training Program
Risk Management
Purchasing and Supplier Control
Receiving Inspection for SaMD
Software Development and Validation
Updates as regulations change
Support via email
digital access + downloadable templates
Preview: Software Development
digital access + downloadable templates
Post-market Toolkit
If you're preparing for launch (or have recently launched), this toolkit is for you. Build upon your QMS to support your organization's commercial efforts. This toolkit includes implementation best practices as well.
Toolkit Contents:
Post-market surveillance
Medical device reporting
Customer inquiry and complaint handling
Updates as regulations change
Technical support
Contract Review
Recall plan
Interacting with the FDA
Internal audit plan
Support via email
digital access + downloadable templates
Preview: Post-Market Surveillance
Select your plan
Each toolkit comes with customizable templates and instructions. You will receive a link to download the toolkit after purchase. No subscription required.
Plan #1
Pre-market Toolkit
Build the foundation of your QMS to align with design and development.
$599
Plan #2
Prepare your QMS to support your organization's commercial efforts.
$699
Plan #3
Everything you need for your QMS, from pre to post market. Get the most value with this bundle.
$1099
Frequently asked questions
What are the QMS toolkits?
The QMS toolkits are a resource for startups and early-stage companies to create a quality system from scratch. Each toolkit contains instructions and templates that are designed to be customized with your company’s information. The step-by-step instructions enable a self-guided process so you can move at your own pace. There are two toolkits - one for pre-market products and one for post-market products.
What is the difference between the pre-market and post-market toolkits?
The pre-market toolkit is designed to help companies build their initial quality system for inclusion in a regulatory submission.
The post-market toolkit is designed for companies who have a product in market and need to build upon their QMS to meet additional compliance regulations.
How will I receive the toolkit after purchase?
After purchasing the toolkit, you will receive an email confirmation that includes a link to download the templates for your QMS. Please note the templates are in MS Word format. You will also receive access to a portal that contains all the instructions and guidance.
Can I purchase select documents instead of the entire toolkit?
Yes, we offer the templates individually. Please contact us at templates@cosmhq.com to inquire about a specific template and pricing.
How is this toolkit focused on SaMD?
We are developers too and are very sensitive to ensuring there’s the right balance between product development and compliance. We’ve taken our many years of development and compliance experience to adapt the QMS toolkits in a way that ensures you can still leverage Agile and its best practices. In our Software Development procedure, we define leveraging an Agile approach but also provide enough flexibility to allow your teams to leverage whatever methodology you want.
We also provide elements in Risk Management that are focused on SaMD. Such elements include Cybersecurity, Interoperability, Usability, and Artificial Intelligence. There are many types of SaMD so it’s important that you tailor your procedures to ensure it applies to your type or product(s) and organization.
How long does it take to build a QMS using the toolkit?
Each company has varying levels of resources when it comes to time, people, and experience. Because each QMS is uniquely built, it is difficult to provide an exact timeframe for completion. From our experience, companies with a dedicated full-time Quality resource have been able to build a QMS in 2-4 weeks for a regulatory submission.
What if regulations change?
We know that regulations change all the time. We will post updates to the toolkit portal that cover the changes and general guidance on how to address these changes. Our documents will be updated accordingly as well.
What if we can’t afford to purchase the templates?
We get it. For early-stage small start-ups with limited or no funding, we are willing to find ways to offer more affordable solutions. Just reach out to us explaining your situation and we will see how we can help. Contact us at templates@cosmhq.com
What if we also develop hardware?
We can support this as well but it is a bit more complex. Reach out to us describing your situation and mention what help you’re looking for. We need to understand your business, your products, your planned processes and more in order to know what and how we can best assist you.
Will I have support from the Cosm team?
As a part of your toolkit purchase, you can book a 30-minute call with one of our Cosm consultants. You will find all guidance and instructions via our toolkit portal. We also offer email support at templates@cosmhq.com.
