At Activem, we offer end-to-end management of your online IFU, so you can save time, reduce costs, and focus on what matters most - your clients and your products. We can enhance traditional paper IFUs by adding features such as videos, multilingual content, and color formatting, creating a customizable and brand-aligned experience. Our standardized processes ensure that the latest version is always available, and we keep you informed about your IFU status at every step of the process. We also handle all technical and logistical aspects of online hosting, so your internal resources can stay focused on core business priorities, all for a minimal fee.

Even if you already have a website, managing IFUs in-house often comes with challenges - in-house resources are limited, websites are rarely flexible or proactively updated, updates lack traceability, reports and version control are missing, and healthcare professionals with time-sensitive responsibilities often face time-consuming navigation just to access the right IFU. These issues not only frustrate users but also increase the risk of non-compliance and liability if accurate information isn’t readily available. At Activem, we provide end-to-end management of your online IFU in a transparent and efficient way - helping you save time, reduce costs, and ensure compliance with EU healthcare device regulations. With our dedicated processes and resources, you can operate with confidence while keeping your focus on what matters most: your products and your clients.

All online documentation is backed up every time a new version is uploaded. In the event of any disruption to the main server, documents can be quickly restored from the backup.

All services are hosted on a secure web server with restricted access to ensure data protection.

With each upload, Activem provides a verification eReport (electronic report) to the client. This report includes a validation section, allowing you to confirm that the correct version of the IFU has been uploaded. We recommend filing and keeping this eReport as documented proof of the upload.

Activem also provides draft Standard Operating Procedures (SOPs) for the upload process, which can be incorporated into your Quality Management System (QMS). Together, the process and the V&V (Verification & Validation) reports offer evidence to support compliance with ISO 9001 or ISO 13485 requirements.

Our processes fulfill the requirements of the European Regulation 2021/2226. A risk analysis as per ISO 14971 and in compliance to Article 5 of EU 2021/2226 is provided by Activem for the provision of eIFUs in addition or instead of paper IFUs. This can be integrated in the manufacturer’s risk analysis and quality management system.

While we are on the course of certifying our services, Activem provides all the documentation to support your Quality Management system.

eIFUs are stored at a dedicated web address (URL) managed by Activem. This web address can be customized and hosted either on a domain provided by Activem or on the manufacturer’s own domain. The manufacturer should redirect each user request to the provided web address. If you prefer to use a custom subdomain (e.g., www.eifu.yourcompanyname.com), we can support you in setting that up as well.

Activem provides printed copies of eIFUs upon request, which can be submitted online. Delivery can be arranged via standard or expedited courier, with shipping costs billed directly to the manufacturer.

The web address can be linked directly from your company's website. In addition, the web address (or QR code) can be included in the product packaging artwork, on a leaflet or simplified IFU within the packaging, or, where possible, directly on the device itself. Contact us to learn more about the different approaches our clients use.

Our process and solutions enable us to support any type of digital documents. In addition to eIFUs, our services are also used for:

• MSDS (Material Safety Data Sheet) per product type

• Certificate of Compliance or Certificate of Analysis per manufacturing lot

• Marketing brochures

• Clinical information

• And much more, contact us for your requirements.

Simply send your updated documents to us by email. To ensure full traceability, all uploads are managed through this process. Activem executes and verifies the upload, archives the previous version, and provides the client with a Verification & Validation Checklist Report by email for validation and record-keeping.

Our cost structure include:

• a one time initial setup fee

• a fixed monthly maintenance fee for:

  • website management

  • archiving

  • servers charges

  • backup activities

  • security services

  • monthly reports

• update fees for each document revision

Contact us for your customized offer.