Your Virtual Chief Regulatory Officer

Bring medical innovation to market while we manage compliance

Trusted by next-gen companies

Human expertise and AI efficiency in one comprehensive product

Implants, digital therapeutics, or cancer diagnostics... All are supported

Complete certification coverage

Cover ISO 13845, 21 CFR, MDR 2017/745, or IVDR 2017/746 and all the associated consensus standards

Next

Clear certification roadmap

All compliance requirements are identified and implemented for your device, no matter how complex

Completed!

Clinical Evaluation

In Progress

Prove your medical device’s safety and effectiveness to ensure it works and is safe for patients.

Completed!

Risk Management

Not Started

Identify, assess, and mitigate potential risks to ensure the safety and effectiveness of your medical device.

Completed!

Traceability Matrix

In Progress

Link requirements to design, testing, and verification to ensure your medical device meets all intended needs.

Completed!

Clinical Evaluation

In Progress

Prove your medical device’s safety and effectiveness to ensure it works and is safe for patients.

Completed!

Risk Management

Not Started

Identify, assess, and mitigate potential risks to ensure the safety and effectiveness of your medical device.

Completed!

Traceability Matrix

In Progress

Link requirements to design, testing, and verification to ensure your medical device meets all intended needs.

Completed!

Clinical Evaluation

In Progress

Prove your medical device’s safety and effectiveness to ensure it works and is safe for patients.

Completed!

Risk Management

Not Started

Identify, assess, and mitigate potential risks to ensure the safety and effectiveness of your medical device.

Completed!

Traceability Matrix

In Progress

Link requirements to design, testing, and verification to ensure your medical device meets all intended needs.

Completed!

Clinical Evaluation

In Progress

Prove your medical device’s safety and effectiveness to ensure it works and is safe for patients.

Completed!

Risk Management

Not Started

Identify, assess, and mitigate potential risks to ensure the safety and effectiveness of your medical device.

Completed!

Traceability Matrix

In Progress

Link requirements to design, testing, and verification to ensure your medical device meets all intended needs.

Completed!

Post-Market Surveillance

Editing

Monitor your medical device’s performance and safety after it’s on the market.

Completed!

Training

Approval Required

Ensure your employees are trained to develop on maintain your medical device.

Completed!

User Needs

In Progress

Identify and prioritize user needs of your medical device.

Completed!

Post-Market Surveillance

Editing

Monitor your medical device’s performance and safety after it’s on the market.

Completed!

Training

Approval Required

Ensure your employees are trained to develop on maintain your medical device.

Completed!

User Needs

In Progress

Identify and prioritize user needs of your medical device.

Completed!

Post-Market Surveillance

Editing

Monitor your medical device’s performance and safety after it’s on the market.

Completed!

Training

Approval Required

Ensure your employees are trained to develop on maintain your medical device.

Completed!

User Needs

In Progress

Identify and prioritize user needs of your medical device.

Completed!

Post-Market Surveillance

Editing

Monitor your medical device’s performance and safety after it’s on the market.

Completed!

Training

Approval Required

Ensure your employees are trained to develop on maintain your medical device.

Completed!

User Needs

In Progress

Identify and prioritize user needs of your medical device.

Completed!

Clinical Evaluation

In Progress

Prove your medical device’s safety and effectiveness to ensure it works and is safe for patients.

Completed!

Risk Management

Not Started

Identify, assess, and mitigate potential risks to ensure the safety and effectiveness of your medical device.

Completed!

Traceability Matrix

In Progress

Link requirements to design, testing, and verification to ensure your medical device meets all intended needs.

Completed!

Clinical Evaluation

In Progress

Prove your medical device’s safety and effectiveness to ensure it works and is safe for patients.

Completed!

Risk Management

Not Started

Identify, assess, and mitigate potential risks to ensure the safety and effectiveness of your medical device.

Completed!

Traceability Matrix

In Progress

Link requirements to design, testing, and verification to ensure your medical device meets all intended needs.

Completed!

Clinical Evaluation

In Progress

Prove your medical device’s safety and effectiveness to ensure it works and is safe for patients.

Completed!

Risk Management

Not Started

Identify, assess, and mitigate potential risks to ensure the safety and effectiveness of your medical device.

Completed!

Traceability Matrix

In Progress

Link requirements to design, testing, and verification to ensure your medical device meets all intended needs.

Completed!

Clinical Evaluation

In Progress

Prove your medical device’s safety and effectiveness to ensure it works and is safe for patients.

Completed!

Risk Management

Not Started

Identify, assess, and mitigate potential risks to ensure the safety and effectiveness of your medical device.

Completed!

Traceability Matrix

In Progress

Link requirements to design, testing, and verification to ensure your medical device meets all intended needs.

Completed!

Post-Market Surveillance

Editing

Monitor your medical device’s performance and safety after it’s on the market.

Completed!

Training

Approval Required

Ensure your employees are trained to develop on maintain your medical device.

Completed!

User Needs

In Progress

Identify and prioritize user needs of your medical device.

Completed!

Post-Market Surveillance

Editing

Monitor your medical device’s performance and safety after it’s on the market.

Completed!

Training

Approval Required

Ensure your employees are trained to develop on maintain your medical device.

Completed!

User Needs

In Progress

Identify and prioritize user needs of your medical device.

Completed!

Post-Market Surveillance

Editing

Monitor your medical device’s performance and safety after it’s on the market.

Completed!

Training

Approval Required

Ensure your employees are trained to develop on maintain your medical device.

Completed!

User Needs

In Progress

Identify and prioritize user needs of your medical device.

Completed!

Post-Market Surveillance

Editing

Monitor your medical device’s performance and safety after it’s on the market.

Completed!

Training

Approval Required

Ensure your employees are trained to develop on maintain your medical device.

Completed!

User Needs

In Progress

Identify and prioritize user needs of your medical device.

Eliminate resource drain

Don't let compliance cost you time and energy, our reliable AI and human experts let you innovate without interruption

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Dedicated experts make sure it's done right

Our team of seasoned experts have years of experience to guide you through any challenge

Our package with Formly is exactly what we wanted and what we needed. No BS, no fluff. Formly's services are straight to the point and the team is so pleasant to work with. As a small business and a startup, that's what you really need.

Anina Langhans
Anina Langhans

Co-Founder & Product Lead LipoCheck

Get to market fast and stay there

Skip the consultant email chains and get your certification and compliance done in record time

Scale your product, not your team

Compliance as a service powerful enough to keep your team lean so you can focus on what matters

FormlyAI

One platform, all your devices

Manage multiple devices at once and eliminate redundant work.

Scale across continents

Breeze through multi-market compliance without drowning in red tape.

Predicable pricing tailored to you

A reliable long-term partner that gives you exactly what you need

Pre-Certification

Fixed Fee

Get on the market fast with us as your regulatory expert. Everything you need for certification covered by one transparent fee.


  • Fully managed regulatory support
  • FDA, MDR, IVDR
  • All product types
  • Quality Management System
  • Technical Documentation
  • eQMS
  • Audit Support
  • PRRC
  • Dedicated Expert

Post-Certification

Annual Fee

Stay compliant effortlessly without draining resources. Our service fits your needs from self-manged to fully outsourced.


  • Fully managed ongoing compliance
  • eQMS
  • Change Assistance
  • Complaint Handling
  • Periodic Reports
  • Surveillance
  • Employee Training
  • Compliance Alerts
  • Dedicated Expert

Happy companies we've certified

Our customers are our best advocates. Here's what they have to say about us.

We know we have the back office covered with Formly. They are hands on and make our medical device compliance easy. You get a team who provides guidance on best practices in the medical device compliance world, and you spend a fraction of the time you would on this work otherwise.

Philipp Piroth

Philipp Piroth

Co-Founder & CEO @ Myoact

Our package with Formly is exactly what we wanted and what we needed —no BS, no fluff. Formly's services are straight to the point and the team is so pleasant to work with. As a small business and a startup, that's what you really need.

Anina Langhans

Anina Langhans

Co-Founder & Product Lead LipoCheck

The more I work on Formly the more it amazes me. Hats off for making a product that is easy to use and immediately brings users insane value!

Dr. Julian Kruse

Dr. Julian Kruse

Co-Founder & CMedO @ coobi

I have been continually impressed with Spencer's Quality and Regulatory expertise. The caliber of industry experience matched with their incredible software is an unbeatable combo.

Angela Frederickson

Angela Frederickson

CEO @ Sparq Compliance

Orcason has joined Formly for their FDA 510(k).

Elias Revonta

Elias Revonta

CEO & Founder Orcason

A reliable, efficient, and cost-effective partner that made navigating a complex regulatory environment with our small team feel easy.

Alberto Villanueva Tormo

Alberto Villanueva Tormo

Co-Founder @ Amaia-App

Leveraging their AI and regulatory expertise dramatically simplified our pathway to EU MDR approval. Would highly recommend!

Michelle Hoffmann

Michelle Hoffmann

Co-Founder @ meal&heal

The quality of service we received from Formly was exceptional. Spencer and his team found the right regulatory strategy for our needs and the software made the execution super easy.

Nicholas Gentry

Nicholas Gentry

Co-Founder @ LifeAhead

We chose Formly as our regulatory partner based on their extensive EU and US market knowledge and the depth of expertise their consultants bring.

Anonymous

Anonymous

Founder @ AI HealthTech Startup

We know we have the back office covered with Formly. They are hands on and make our medical device compliance easy. You get a team who provides guidance on best practices in the medical device compliance world, and you spend a fraction of the time you would on this work otherwise.

Philipp Piroth

Philipp Piroth

Co-Founder & CEO @ Myoact

Our package with Formly is exactly what we wanted and what we needed —no BS, no fluff. Formly's services are straight to the point and the team is so pleasant to work with. As a small business and a startup, that's what you really need.

Anina Langhans

Anina Langhans

Co-Founder & Product Lead LipoCheck

The more I work on Formly the more it amazes me. Hats off for making a product that is easy to use and immediately brings users insane value!

Dr. Julian Kruse

Dr. Julian Kruse

Co-Founder & CMedO @ coobi

I have been continually impressed with Spencer's Quality and Regulatory expertise. The caliber of industry experience matched with their incredible software is an unbeatable combo.

Angela Frederickson

Angela Frederickson

CEO @ Sparq Compliance

Orcason has joined Formly for their FDA 510(k).

Elias Revonta

Elias Revonta

CEO & Founder Orcason

A reliable, efficient, and cost-effective partner that made navigating a complex regulatory environment with our small team feel easy.

Alberto Villanueva Tormo

Alberto Villanueva Tormo

Co-Founder @ Amaia-App

Leveraging their AI and regulatory expertise dramatically simplified our pathway to EU MDR approval. Would highly recommend!

Michelle Hoffmann

Michelle Hoffmann

Co-Founder @ meal&heal

The quality of service we received from Formly was exceptional. Spencer and his team found the right regulatory strategy for our needs and the software made the execution super easy.

Nicholas Gentry

Nicholas Gentry

Co-Founder @ LifeAhead

We chose Formly as our regulatory partner based on their extensive EU and US market knowledge and the depth of expertise their consultants bring.

Anonymous

Anonymous

Founder @ AI HealthTech Startup

We know we have the back office covered with Formly. They are hands on and make our medical device compliance easy. You get a team who provides guidance on best practices in the medical device compliance world, and you spend a fraction of the time you would on this work otherwise.

Philipp Piroth

Philipp Piroth

Co-Founder & CEO @ Myoact

Our package with Formly is exactly what we wanted and what we needed —no BS, no fluff. Formly's services are straight to the point and the team is so pleasant to work with. As a small business and a startup, that's what you really need.

Anina Langhans

Anina Langhans

Co-Founder & Product Lead LipoCheck

The more I work on Formly the more it amazes me. Hats off for making a product that is easy to use and immediately brings users insane value!

Dr. Julian Kruse

Dr. Julian Kruse

Co-Founder & CMedO @ coobi

I have been continually impressed with Spencer's Quality and Regulatory expertise. The caliber of industry experience matched with their incredible software is an unbeatable combo.

Angela Frederickson

Angela Frederickson

CEO @ Sparq Compliance

Orcason has joined Formly for their FDA 510(k).

Elias Revonta

Elias Revonta

CEO & Founder Orcason

A reliable, efficient, and cost-effective partner that made navigating a complex regulatory environment with our small team feel easy.

Alberto Villanueva Tormo

Alberto Villanueva Tormo

Co-Founder @ Amaia-App

Leveraging their AI and regulatory expertise dramatically simplified our pathway to EU MDR approval. Would highly recommend!

Michelle Hoffmann

Michelle Hoffmann

Co-Founder @ meal&heal

The quality of service we received from Formly was exceptional. Spencer and his team found the right regulatory strategy for our needs and the software made the execution super easy.

Nicholas Gentry

Nicholas Gentry

Co-Founder @ LifeAhead

We chose Formly as our regulatory partner based on their extensive EU and US market knowledge and the depth of expertise their consultants bring.

Anonymous

Anonymous

Founder @ AI HealthTech Startup

We know we have the back office covered with Formly. They are hands on and make our medical device compliance easy. You get a team who provides guidance on best practices in the medical device compliance world, and you spend a fraction of the time you would on this work otherwise.

Philipp Piroth

Philipp Piroth

Co-Founder & CEO @ Myoact

Our package with Formly is exactly what we wanted and what we needed —no BS, no fluff. Formly's services are straight to the point and the team is so pleasant to work with. As a small business and a startup, that's what you really need.

Anina Langhans

Anina Langhans

Co-Founder & Product Lead LipoCheck

The more I work on Formly the more it amazes me. Hats off for making a product that is easy to use and immediately brings users insane value!

Dr. Julian Kruse

Dr. Julian Kruse

Co-Founder & CMedO @ coobi

I have been continually impressed with Spencer's Quality and Regulatory expertise. The caliber of industry experience matched with their incredible software is an unbeatable combo.

Angela Frederickson

Angela Frederickson

CEO @ Sparq Compliance

Orcason has joined Formly for their FDA 510(k).

Elias Revonta

Elias Revonta

CEO & Founder Orcason

A reliable, efficient, and cost-effective partner that made navigating a complex regulatory environment with our small team feel easy.

Alberto Villanueva Tormo

Alberto Villanueva Tormo

Co-Founder @ Amaia-App

Leveraging their AI and regulatory expertise dramatically simplified our pathway to EU MDR approval. Would highly recommend!

Michelle Hoffmann

Michelle Hoffmann

Co-Founder @ meal&heal

The quality of service we received from Formly was exceptional. Spencer and his team found the right regulatory strategy for our needs and the software made the execution super easy.

Nicholas Gentry

Nicholas Gentry

Co-Founder @ LifeAhead

We chose Formly as our regulatory partner based on their extensive EU and US market knowledge and the depth of expertise their consultants bring.

Anonymous

Anonymous

Founder @ AI HealthTech Startup

Frequently Asked Questions

Answers to common questions about FormlyAI and its features

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