Medical devices technical file

Eumed® is a company specialized in supporting manufacturers in drafting technical dossiers, ensuring compliance with Annexes II and III of the (EU) Regulations MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Medical Devices Regulation), including clinical and follow-up requirements. Thanks to its in-depth regulatory knowledge and vast experience in the sector, Eumed® supports customers not only in drafting documents, but also in the correct identification of the risk class of medical devices and in the compliance process, which may require the intervention of a notified body.

Furthermore, for free-sale products, Eumed® creates complete product technical files, ensuring full compliance with Regulation (EU) 2023/988. This integrated approach allows manufacturers to confidently address regulatory complexities, reducing risks and accelerating time to market for medical devices and free-market products.

FTE: Eumed's technical file for medical devices®

The original Eumed solution®: Easy, efficient, always in step with the regulations

FTE of Eumed® is the first and original instrument available on the market to organize and manage all related technical documentation to medical devices and freely available products, including systems and kits for the operating room. A system validated by industry experts according to the ISO TR 80002:2017 standard.

FTE of Eumed® is the solution that allows you to create and update the Technical File for medical devices, of the in vitro diagnostic medical devices and free-sale products in a safe and intuitive way, thanks to the guided procedure. To organize, manage and protect documentation in full compliance with regulations with maximum simplicity.

FTE is a solution that can be customized to the specific needs of customers, following their particular indications also for particular specialist sectors (e.g. dental technicians).

FTE is a software developed specifically for the rapid and effective organization and management of technical documentation relating to medical, in vitro diagnostic medical devices and free-sale products. FTE allows you to create and update the Electronic Technical File of medical devices in just a few clicks, protecting data thanks to a reliable and regulatory compliant cloud platform. A tool that simplifies processes and allows you to manage documentation from multiple devices, keeping track of all files, changes made and expired and expiring documents. All in compliance with EU Regulation no. 2017/745 on medical devices and EU Regulation no. 2017/746 on in vitro diagnostic medical devices.

For all operators in the world of medical devices

FTE is a tool designed for all economic operators that revolve around the world of medical devices (MD), of the in vitro diagnostic medical devices (IVD) and goods free-sale products in accordance with the Regulation (EU) 2023/988.

An essential support also for distributors and importers of medical devices who operate in full compliance with European regulations, while offering an effective tool to demonstrate the validity of their documents to the supervisory bodies.

The advantages

Simplification of regulatory and work processes

A single platform to manage all documentation uniformly, keeping track of files, changes, documents, deadlines.

Time and resources saved

With FTE, the management of the Electronic Technical File becomes effective and standardized, thanks to an error-proof guided procedure. All Technical Files can be managed and organized in a single digital space.

Total dematerialization

Say goodbye to paper and embrace a digital solution that not only allows you to completely eliminate paper documents, but also avoid the deterioration that often affects physical documents. With FTE, your files will always be safe, tidy and easily accessible, without the risk of losing precious data due to wear and tear or time. Make your business more efficient and sustainable with our document management solution.

Flexibility and simplicity

The software solution is available both in the cloud and in-house. You won’t have to worry about complex installations or keeping the system up to date: our software updates automatically, always guaranteeing maximum efficiency. Furthermore, our solution is accessible from all common browsers, allowing you to work anywhere, anytime, without limitations. Ease of use, continuous updates and accessibility: the future of document management is here!

Continuous update

The software solution evolves with the regulations, to always guarantee maximum compliance.

Guaranteed safety

Protect your documentation with our document management software, which guarantees that your files cannot be tampered with. Each document is protected by advanced security measures, preventing unauthorized alterations and ensuring the integrity of the information. Additionally, our system offers precise profile and user management, allowing you to control who can access, view or edit documents. With our solution, you can rest assured that your data is safe, managed securely and accessible only by those authorized.

Precise management

Our document management software offers accurate management of the validity of documents associated with Technical Files (FT). You will be able to monitor deadlines, updates and compliance, avoiding errors and ensuring that each document is always valid and updated. Furthermore, our solution allows the simultaneous management of multiple Technical Files, simplifying the duplication process in the presence of variants. Whether you need to manage complex documents or multiple versions of the same file, our software gives you total control and unparalleled precision.

To track documents and manage deadlines

All the functions to manage the Product Technical File with FTE

The management of technical documentation is a complex and time-consuming process.
FTE provides numerous features that simplify the work of operators and guarantees complete data protection.

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