We Simplify Market Access for Medical Devices - Decomplix

Nicolas Höfler Groupe Mutuel, Switzerland «Decomplix gives us the necessary security in the use of software as a medical device during digitalization.» Renate Reiss Neodynamics AB, Sweden «Due to service quality, regulatory knowledge, and reliability, we can highly recommend Decomplix as CH-REP.» Dr. Corina Matzdorf ulrich GmbH & Co. KG, Germany «Being a German high-quality manufacturer for medical devices with more than 110 years of experience and operating worldwide, we feel very safe with Decomplix.» Manuel Baumann Oviva AG, Switzerland «We benefited tremendously from Decomplix's experience and expertise in working with the Swiss authority, Swissmedic, and with Notified Bodies.» Benjamin Schlenker Canvys – Visual Technology Solutions, Germany «With Decomplix as our CH-REP and partner, we feel well-supported. The collaboration is exceptionally professional and efficient.» Teija Ålander Orkla – Wound Care, Sweden «We are very satisfied with the support and helpful knowledge of Decomplix as CH-REP.» Susanne Vesterinen RFSU AB, Sweden «It feels very good to have Decomplix as CH-REP.» Florian Schulz OBERON GmbH Fiber Technologies, Germany «Decomplix offers a professional approach and streamlined process for compliance and specific requirements of the Swiss market.» Claudia Handler CARE diagnostica, Austria «We appreciate the clear procedure, the professional approach, and the uncomplicated cooperation and highly recommend Decomplix as a business partner.» Jonas Widmer Balgrist University Hospital, Switzerland «With the regulatory evaluation of our planning software, we were able to take key steps in product development with Decomplix.» Eric Tscharner HASA OPTIX, Belgium «As a premium manufacturer of ophthalmic instruments, we feel very secure with Decomplix.» Dominik Gutzler CytoSorbents Europe GmbH, Germany «Decomplix as CH-REP is our partner of choice, providing us with a great comprehensive service and allowing us to focus our internal resources on other projects.» Sang-Il Kim Federal Office of Public Health FOPH, Switzerland «Decomplix has done an excellent job for the SwissCovid App while working under high pressure. The team is reliable, fast and extremely competent.» Alain Kamm Sanitas Health Insurance, Switzerland «For our digital health initiatives, we feel we are in safe hands with Decomplix.» Thomas Farner Axon Lab AG, Switzerland «Thanks to Decomplix' great expertise, pragmatic approach and support, we were ready for the CH requirements for IVD/MD importers and CH-REPs within a short time.» Runa Emura Konan Medical Inc., Japan «Decomplix quickly provides us with new and updated information on medical devices in Switzerland. We are very satisfied with their service.» José Näf nahtlos GmbH, Switzerland «Decomplix' Regulatory Support helps us quick and uncomplicated — I can thoroughly recommend it to any medical start-up.» Matías Hosiasson Biomedical Devices SpA, Chile «Decomplix took a pragmatic approach and enabled us to make an informed decision on the regulatory pathway.» Hemera Beretta NeuroPro AG, Switzerland «Decomplix provided valuable expertise for understanding the regulatory framework of medical device, data protection and IT security.» Pascal Reichmuth Rikai AG, Switzerland «Thanks to the comprehensive strategy workshop with Decomplix, we understand how to classify and develop our product Rikai as medical device software and what rules apply in the development.» Markus Piller Medid AG, Switzerland «The flexibility, broad-based expertise and the will to always find a suitable solution for our problems as a small MedTech company are qualities we greatly appreciate about Decomplix.»