1MED SA

medical devices

About

1MED SA is a Swiss-based Contract Research Organization (CRO) located in Agno, Ticino. Founded in 2014, the company specializes in regulatory, clinical, and quality services for pharmaceutical, biotechnology, and medical device companies. 1MED supports clients of all sizes, from small and medium-sized enterprises to large corporations, in navigating the complexities of regulatory frameworks, particularly the European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The company offers a range of services, including regulatory strategy and support, clinical trial management, quality assurance, and post-market activities. 1MED also develops digital solutions to enhance compliance and streamline processes. With a strong track record, the company has successfully supported the certification of over 300 medical devices, achieving a 100% product approval rate. 1MED aims to be a trusted partner in guiding medical technologies from innovation to commercialization, focusing on compliance, quality, and client collaboration.

Technologies

Outlook Microsoft Office 365 GoDaddy Hosting WordPress.org reCAPTCHA Mobile Friendly McAfee Hotjar Google Analytics Google Tag Manager Apache Vimeo Cedexis Radar Shutterstock Adobe Media Optimizer Google Maps Google Maps (Non Paid Users) Bootstrap Framework Google Font API AI

Keywords

contract research organization biotechnology medical devices clinical regulatory strategy medical device development life sciences clinical trials regulatory intelligence mdr medical equipment manufacturing clinical study design fda approval support regulatory submission support quality systems regulatory audit support research and development in the physical engineering and life sciences medical device regulation post-market services ce marking biotech clinical development medical device innovation support clinical study management medical device lifecycle medical device compliance real-world data clinical trial monitoring risk management clinical investigation support

Location

13 Via Campagna, Agno, Ticino, Switzerland, 6982

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