Services

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.

Our services include:

Oursourced 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!

Plug and Play QMS :

Get your own EN ISO 13485, MDR/IVDR and FDA -compliant quality management system package to accelerate your time to market.

Plug and Play QMS Bootcamp :

Flexible training options to deepen your expertise and enable self-management
of your quality management system.

Rent an Expert :

Expand your team by renting one or several of our specialized professionals in quality management and regulatory affairs.

Regulatory Opinion :

Leverage our expert insights for global compliance
and market access strategies.

AI/ML Device Certification :

Efficient, compliant certification for AI and
machine learning-based solutions.

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