China's Best One-Stop Medical Equipment Provider
About

Effectum Medical AG, located in Olten, Switzerland, is a company builder and legal manufacturer in the MedTech and in-vitro diagnostics (IVD) sectors. The company focuses on supporting innovators by bridging the gap between medical device ideas and their market implementation. Effectum Medical accelerates innovation and reduces risks by providing access to a comprehensive quality management system (QMS) and regulatory expertise. The company offers a variety of services, including outsourced legal manufacturing, a Plug & Play electronic Quality Management System (eQMS), and regulatory consulting. They assist throughout the entire product lifecycle, ensuring compliance with medical device regulations such as MDD, MDR, and IVDD. Additionally, Effectum Medical acts as the Swiss Authorized Representative for foreign medical device manufacturers, helping them meet Swiss regulatory requirements. With a team that combines MedTech business experience and regulatory knowledge, Effectum Medical supports MedTech startups and companies in developing, certifying, and commercializing innovative medical devices and diagnostics. Their services aim to reduce time-to-market and enhance the chances of commercial success for healthcare innovations.

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Keywords
diagnosticshealthtechivdehealthhealth carespinoffsstartupsmedtechinnovationfoundersmedical equipment manufacturingregulatory affairsoutsourced legal manufactureroperational efficiencyplug-and-play qmsproduct registrationtraining and supportmedical device startup supportcost-effective manufacturingconsultingservicesmdr/mdr complianceproduct lifecycle managementmedical device legal manufacturingregulatory pathway optimizationproduct certificationeuropean and us marketpost-market surveillancecompliance managementiso 13485
Company Information
  • Employees12
  • Founded2017
Location

11 Kirchgasse, Olten, Canton of Solothurn, Switzerland, 4600

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