Why Activem, And Why Now?

Activem is your complete solution for managing Instructions for Use digitally (eIFUs). We fully host, maintain, and manage your multilingual  eIFUs - so you don’t have to worry about compliance overhead or technical complexities. Simply choose one of our customizable templates and send us your eIFUs as they become available. We’ll provide you with a secure, branded, multilingual eIFU directory that ensures version control, enhances user experience, and includes optional print-on-demand services for paper copies when needed.​ 

 

Our platform is built with compliance in mind - meeting regulatory standards for personal data protection and eIFU availability. Activem is committed to delivering services in compliance with EU Regulations 2017/745, 2017/746, and 2021/2226. We support your compliance by providing documentation that integrates seamlessly into your quality management system - including an EN ISO 14971 risk management file, an ISO 13485 Section 7.3 design matrix, and traceable verification and validation records for every upload. We also provide regular reports of all currently hosted documents to support your internal audit requirements.

 

Your eIFU site is securely hosted and optimized for high availability to ensure uninterrupted access to critical information across all modern browsers and devices.​ With Activem as your partner, there’s no need for you to allocate internal resources to manage eIFUs. No added personnel. No added complexity. Just a streamlined, cost-effective solution that let's you focus on what matters most - your products and your clients.