1MED SA Regulatory & Clinical development

Short description

1MED is a leading European Medtech boutique CRO, focused on preclinical, regulatory, clinical development and quality management systems, highly specialized within the medical devices, combination products and IVDs fields.

Standards, Products, Services

  • S Further services development
  • S Topology optimization
  • S Technology development
  • S Consulting
  • S Documentation
  • S Registration of medical devices
  • S Further services for manufacturers
  • S Further research and development
  • S Further services
  • S Further quality assurance
  • S Training
  • S Data analytics
  • S Further contract manufacturing
  • S Clinical trials
  • S Risk management

About us

1MED  is a leading European MedTech Contract Research Organization (CRO) offering global end-to-end development services.

1MED's clinical research services include clinical study management, post market studies, biostatistics and data management, safety reporting and imaging core lab services. Our clinical research teams are comprised of the MedTech industry’s foremost experts, with experiences that span every manner of technology, therapy, indication and geography for clinical research. This broad range of experience allows 1MED’s teams to lead our clients through all phases of clinical research: from preclinical all the way through first in human, pivotal and post-market studies.

Founded in 2014, with headquarter in Agno, Switzerland, 1MED's mission is to provide the European MedTech market complete clinical research solutions to accelerate scientific outcomes to their clients. Our team of researchers utilize its vast expertise across all areas of clinical research and cutting-edge data solutions to support our customers across the clinical research continuum.

1MED works with clients that are either SMEs or big medtech companies to support them in facing the complexity associated with the development of innovative medical devices in compliance with MDR by providing support from a strategic, regulatory, quality and clinical point of view, with a cross-functional approach which led to win the certification and certification maintenance of more than 500 different medical devices.

Apposite Capital, the healthcare specialist private equity investor, represents the main shareholder of 1MED, and is working with the 1MED and EVAMED management team to continue to strengthen and widen the company’s service offering and further expand its geographic coverage.