1MED, is the leading European MedTech specialized solutions provider,
offering end-to-end development expertise within the medical device, novel technology and combination products fields.

Founded in 2014, with headquarter in Agno, Switzerland, and employing 100+ professionals across the Europe, 1MED's mission is to support all the MedTech organizations in facing the complexity associated with the development of innovative medical devices in compliance with MDR.

Such support may include providing preclinical support, regulatory advice, clinical study management, post marketing support and quality management systems across the clinical research continuum with a cross-functional approach which led to win the certification and certification maintenance of more than 500 different medical devices in the last 2 years only.

1MED not only offers a broad range of internal competences, our clients in fact can trust on a preferred partners network and consolidated relationships with European Notified Bodies and Competent Authorities.  

There is much more to know about us! Please visit  https://www.1med.ch/ to learn about the solutions we can offer or e-mail us: info@1med.ch 

Clinical Trials

Health Care

Life Sciences

Medical Devices

Therapeutics

1MED SA

1MED SA's headquarters in Agno, Switzerland

Enrico Perfler

Philippe Roux

David Bird

Hella Khemiri

The Clinical Operations Team at 1MED SA is responsible for managing and executing clinical studies to ensure the successful development and regulatory approval of innovative medical devices. They oversee all aspects of clinical trial management including study design, implementation, data collection and analysis, and compliance with regulatory requirements. This team ensures that clinical trials are conducted efficiently, ethically, and in alignment with EU MDR standards.

Clinical Operations Team

The Leadership Team at 1MED SA is responsible for the strategic direction and overall management of the company. Comprising the Interim Group Sr Clinical Operations Director / COO, Chief Commercial Officer, Interim Group CFO, and CEO and Founder, this team focuses on steering the company's mission to support MedTech organizations in developing innovative medical devices. Key responsibilities include setting corporate goals, overseeing operations, driving commercial strategies, financial management, and ensuring compliance with MDR regulations.

Leadership Team

The Regulatory Affairs Team at 1MED SA is responsible for ensuring that medical devices, novel technologies, and combination products developed by the company and its clients meet all regulatory requirements. This includes providing strategic regulatory advice, preparing and submitting documentation for certifications, managing communications with European Notified Bodies and Competent Authorities, and ensuring ongoing compliance with the Medical Device Regulation (MDR). The team plays a critical role in facilitating the successful market entry and maintenance of innovative medical products.

1MED SA

Org chart

Teams

Clinical Operations Team

Leadership Team

Regulatory Affairs Team

Offices

1MED SA

Org chart

Teams

Clinical Operations Team

Leadership Team

Regulatory Affairs Team

Offices

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