CE marking your medical device, made easy
Every medical device's CE mark starts with a technical file
It is the gateway to your CE mark because it provides the proof that you meet the EU medical device regulations.
Benefits
Easily create your technical file
Documents missing?
Identify what is missing from your device’s documentation using our technical file to serve as your single source of truth.
Confused by regulations?
Find the right path to approval in the EU from a partner you can trust. Our guided technical file takes the guesswork out of EU regulations.
Things taking too long?
Get to CE marking faster with our guided technical file software assisted by AI that automatically fills your information in for you.
Our solutions simplify the medical device regulatory process to elevate healthcare.
Guided Electronic Technical File
Our software provides step-by-step guidance through EU MDR 2017/745 requirements to create a technical file in an easy, fast, and cost-efficient way for you and your business.
AI Parsing and Filling Assistant
Harness the power of AI to parse information and build regulatory documentation for you.
Consultation
We help you one-on-one with your individual regulatory needs and questions.
Document Templates
Missing something? We provide templates for any documentation you might be missing.
Coming soon
Certification and CE Marking Checklists
Checklists help you quickly check if your documentation is ready for CE-marking
Why Trust Formly?
Privacy by Design
Privacy is our core to our business and we ensure the protection of personal data processed by our software by having robust encryption and authentication architecture in place.
Full Compliance
Sometimes staying in compliance is like hitting a moving target. Our technical file and document templates are continually updated to help you conform to MDR 2017/745, ISO 14971, IEC 62304, ISO 62366, and ISO 13485.
Experts you can trust
Our team has regulatory experts trained to get your product up to standard and out to those who need it.
What do clients and experts say about us?
"With the combined experience in medical device regulation and software development, the team from Formly is stellar!"
"They know medical device regulation well and also know what constraints medical companies and founders face. With their expert help and guidance we quickly found a feasible, real world solution."
Spencer and his team have deep expertise in the medical device industry and helped us navigate the complex ins and outs of healthcare regulation. I would recommend them to any founder who is wondering whether they classify as a medical device, or who wants to start the journey of obtaining medical device conformity.
Pricing
Plans that fit your scale
Free plan
$0 / month
Our plan for small teams
FEATURES
Everything you need to get started.
Create a technical file for 1 device
1 free consulting session
Limited AI auto filling
CE marking checklists
Document templates
Try for free
Business plan
Flexible pricing built to work for your business
For companies with advanced needs
FEATURES
Everything in our basic plan plus....
Create technical files for unlimited devices
Lower rates on consulting sessions
Unlimited AI auto filling
Priority support
+ many more...
Get in touch
Free plan
Our most popular plan for small teams.
$0per month
FEATURES
Everything you need to get started.
Technical file access
Document templates
Document parsing (Coming soon)
CE-marking checklists
Try for free
Business plan
Popular
Advanced features and reporting.
Request
FEATURES
Everything in our basic plan plus....
2 consulting sessions/month
Early feature access
Priority support
+ many more...
Get started
Basic plan
Everything you need to get started.
$159per month
FEATURES
Everything you need to get started.
Technical file access
Document templates
1 initial consulting session
Document parsing (Coming soon)
CE-marking checklists
Try for free
Business plan
Popular
Advanced features and additional guidance.
$399per month
FEATURES
Everything in our basic plan plus....
2 consulting sessions/month
Early feature access
Priority support
Add-on consulting sessions
+ many more...
Try for free
What do clients and experts say about us?
Amazing dashboard loved it very much.
"Spencer and his team have deep expertise in the medical device industry and helped us navigate the complex ins and outs of healthcare regulation. I would recommend them to any founder who is wondering whether they classify as a medical device, or who wants to start the journey of obtaining medical device conformity."
Exactly what i was looking for loved it.
"They know medical device regulation well and also know what constraints medical companies and founders face. With their expert help and guidance we quickly found a feasible, real world solution."
Amazing dashboard loved it very much.
"With the combined experience in medical device regulation and software development, the team from Formly is stellar!"
News & Blog Posts
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Frequently Asked Questions
What is the CE marking process for medical devices?
- Determine the applicable regulations and standards for the device, based on its classification and intended purpose.
- Conduct relevant tests, risk assessments, and clinical evaluations to demonstrate that the device is safe and performs as intended.
- Create technical documentation and a technical file to demonstrate that the device meets the safety and performance requirements as stated by MDR 2017/745.
- Under go a conformity assessment audit from a notified body for your quality management system and technical documentation (unless Class I self-certify).
- Prepare a Declaration of Conformity.
- Apply the CE mark to the device and its packaging, along with any relevant accompanying documentation.
- Maintain ongoing surveillance and monitoring of the device to ensure continued compliance with regulations and standards.
What are certification and CE marking checklists and why are they important?
The regulatory requirements for medical devices are extensive and require tedious review to in order to make sure each requirement is met. Certification and CE marking checklists provide both a roadmap of those requirements and an easy final check to ensure you have everything you need to get your CE mark.
What is Guided Technical File generation?
Guided Technical File (GTF) generation is a process used to help users create the Technical File required for the CE marking of a product. The Technical File is a document that demonstrates that a product meets the relevant European Union (EU) standards for safety and performance of a medical device. The GTF provides step-by-step process to assist you in producing and documenting the necessary documentation for CE marking, such as product specifications, test reports, product assessments, risk management, and clinical evaluations in a streamlined and easy to follow format. Contact us for more on GTF.
What is a CE mark and why is it important for my business?
CE is an abbreviation of "conformité européenne" which equates to European conformity. CE marking indicates that a product has been assessed and deemed to meet EU safety, health and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU. CE marking is especially important for medical devices which must meet a high regulatory standard before being allowed on the market.
