May 5, 2023
What is a QMS? A basic guide to ISO 13485.
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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.
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Certification and CE Marking Checklists
Formly checklists are easy to read and get you on your way to CE marking without delay.
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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.
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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.
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!"
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!"
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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 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 extensive review to in order to make sure every requirements is met. Certification and CE marking checklists for medical device manufacturers 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 businesses 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 process provides step-by-step guidance to assist you in producing and documenting the necessary documentation, such as product specifications, test reports, product assessments, 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.
