REGULATORY AND CLINICAL SERVICES: FROM BENCH TO MARKET

A FULL SERVICE CRO OBTAINING PREDICTABLE OUTCOMES, ON TIME AND BUDGET

1MED is an ISO 13485 certified contract research organization which provides regulatory strategy, quality assurance, clinical trial management, and device development services to the medical device and pharmaceutical industry. We retain an in-house expertise in the design, engineering and approval of medical devices, combination products and in vitro diagnostics.

We are a multi-disciplinary team with over 35 years of experience and a consolidated background in medical device development and testing, regulatory affairs, quality assurance and clinical trials management. With our broad range of an internal competences and preferred partners network, we are in a unique position to help our clients advance the development of breakthrough medical device technologies.

Fully Bespoke Outsourced Model

1MED supports its clients throughout the entire lifecycle of their products. Whatever your goals, we help you reach them in a predictable, affordable and timely manner. We know one size doesn't fit all, that is why at 1MED we work with you to best tailor our offer to fit your request and exigencies. 

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Pre-Clinical & Clinical Trial Planning and Implementation

At 1MED we design, set up and executs pre-clinical and clinical trials for drugs and medical devices without overlooking regulatory challenges. We plan, manage, and incorporate reliable, useful, and repeatable pre-clinical and clinical data for smooth regulatory approval. Our proactive approach providing study specific training ensures that issues are communicated and resolved in near real-time whilst never loosing focus on the study's primary objective.

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Regulatory Affairs & Quality Assurance

Staying on top of changing regulatory guidelines and requirements is a must. Paying attention to emerging trends in submission procedures and technologies is a bonus. 1MED does both. Do not get caught up in a regulatory quagmire.

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Device & Pharmaceutical Product Development

An innovative drug or medical device will not achieve certification without adequate planning and support. Let 1MED work with you to grow your ideas and to bring your product to market. During the entire lifecycle of your pharmaceutical product or medical device, 1MED will assist you with a range of strategically tailored solutions. From prototype design to validated batch production 1MED has the know-how and network to make your idea a reality.

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