Effectum Medical AG

Effectum Medical AG, based in Olten, Switzerland, specializes in regulatory, quality, and compliance support for the MedTech and IVD industries. Founded with the mission to accelerate innovation, the company focuses on guiding start-ups and established players through complex European and international regulatory challenges. The team at Effectum Medical brings deep expertise in quality management systems, regulatory affairs, and legal manufacturing, supporting clients from product development through certification and market entry.

Services offered include:

• Legal Manufacturer services (we become the official manufacturer of your device and take over QMS and regulatory registration requirements)
• Quality Systems implementation and maintenance
• Regulatory affairs consulting (MDR, IVDR, FDA)
• Internal and Supplier auditing
• Training and other tailored consulting