info@1med.ch

Your global
end-to-end
development partner
in MedTech

We are a leading international MedTech industry-specialized solutions provider, offering global end-to-end development expertise within the medical device, novel technology and combination products fields.

Leading the way in MedTech solutions as a Group

At 1MED Group, we are dedicated to continuous growth and excellence.

As an expanding company, we thrive on the collective experiences and expertise of all the companies within our network. This collaborative approach allows us to evolve and adapt while strengthening our capabilities and enhancing our reliability.

Our commitment to growth means we are always learning, innovating, and improving. By integrating the diverse knowledge and skills from each company in our portfolio, we can offer comprehensive, cutting-edge solutions to our clients. This synergy not only makes us stronger but also ensures we remain a trusted partner in the medical device and pharmaceutical industries across all phases of development.

Solutions

We are committed to ensuring the success of your projects by providing holistic guidance on product development, starting with the implementation of Quality Management Systems meeting ISO 13485 standards, regulatory consultancy for Technical Documentation and Clinical Evaluations compliant with MDR and IVDR, and comprehensive support for clinical studies across all phases in Europe and beyond. Additionally, through our partnership with 1LAB, we develop tailored experimental protocols for medical devices, ensuring compliance with regulatory requirements.

Quality
Services

We offer customized regulatory and quality solutions designed for medical device companies.

Preclinical
Services

Leverage
our Expertise to define
your preclinical strategy.

Clinical Services for MedTech

We provide end-to-end support covering each step of a clinical investigation, from First In Human (FIH) to observational registries.

Clinical Services for Biotech & Pharma

We support companies through every stage of clinical development, offering tailored solutions that streamline regulatory pathways and accelerate the launch of safe, effective therapeutics.

Regulatory Services

We offer customized regulatory and quality solutions designed for medical device companies.

Post-Market Services

Providing a comprehensive post-market support to ensure regulatory compliance and enhance the safety and performance of your medical device throughout its lifecycle.

Why us

We tackle your challenges as our own, accelerating the regulatory and commercial processes of your medical devices, combination products, and in vitro diagnostics. As an ISO 13485 certified company, we blend reliability with the agility of a start-up, offering regulatory support, digital solutions, and full-service CRO assistance.

Our lean, transparent approach ensures clear insights into risks, benefits, costs, and timelines. With global expertise and a dedicated MedTech focus, we advance your projects from innovation to commercialization, improving patient health and well-being. Together, we are dedicated to realizing your vision, and united, we will achieve extraordinary success.

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