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.
Smart Document System
Experience seamless smart document management with unparalleled security and encryption. Our encrypted system ensures the safekeeping and constant updating of your documents, allowing for improved efficiency, quality and peace-of-mind.
AI Parsing and Filling Assistant
Harness the power of AI to parse information and build regulatory documentation for you.
Certification and CE Marking Checklists
Formly checklists are easy to read and get you on your way to CE marking without delay.
Experience seamless smart document management with advanced security and encryption. Our encrypted system ensures safekeeping and expedient document uploading, improving your efficiency, quality and peace-of-mind.
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.
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.
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Frequently Asked Questions
Below find a selection of frequently asked questions related to our products and services.
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.