Effectum Medical AG supports companies at every stage of developing and launching innovative medical devices. From acting as a legal manufacturer to providing a ready-to-use (e)QMS and certifying AI-based solutions, 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. |
Leverage our expert insights for global compliance |
Artificial Intelligence (AI) / Machine Learning (ML) Device Certification : Efficient, compliant certification for AI and |
CH-REP (Swiss Authorized Representative) : : Secure Swiss market access with our trusted local representation. For a personalized quote and more information on our services, please visit the Effectum CH-REP AG website. Here, you will find detailed insights into our offering and how we can support your needs. |
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With Effectum Medical AG, you have a reliable partner combining innovation with regulatory excellence.
Find the entire overview of our services here: Effectum-Medical-Service-2024_2025
