Effectum Medical AG supports companies at every stage of developing and launching innovative medical devices. From acting as a legal manufacturer to providing a configurable plug & play (e)QMS package, we guide you through the entire process. With certified processes and a flexible team of experts, we ensure you can focus on product development while we manage regulatory requirements efficiently.
Outsourced Legal Manufacturer : Rely on our proven legal manufacturer role to streamline market access and compliance. Want to launch fast? Ask about our fast-track option! |
Get your own EN ISO 13485, MDR/IVDR and FDA -compliant quality management system package to accelerate your time to market. |
Flexible training options to deepen your expertise and enable self-management |
Expand your team by renting one or several of our specialized professionals in quality management and regulatory affairs. |
Obtain a regulatory opinion for your product relating to product classification for EU and US markets and certification strategy. |
We assist you to ensure compliance of AI and machine learning-based medical devices and QMS management.AI/ML Devices Expert |
With Effectum Medical AG, you have a reliable partner combining innovation with regulatory excellence.
Find the entire overview of our services here: Effectum Medical Services
