About us

1MED is a Contract Research Organization providing regulatory strategy, clinical trial management and quality assurance services to the medical device and pharmaceutical industry.
In 1MED we work side-by-side with clients to design and implement competitive and cost-effective regulatory and clinical strategies, to prepare and submit a reviewer-friendly technical documentation and to provide tailored assistance in the negotiation with national and international Notified Bodies and other international regulatory and Competent Authorities.
We are constantly developing new side services such as – among others – PMCF studies and real-world data collection, clinical development plan, Technical File full maintenance (e-TF, TF update) and PMS update.

About us

1MED is a Contract Research Organization providing regulatory strategy, clinical trial management and quality assurance services to the medical device and pharmaceutical industry.
In 1MED we work side-by-side with clients to design and implement competitive and cost-effective regulatory and clinical strategies, to prepare and submit a reviewer-friendly technical documentation and to provide tailored assistance in the negotiation with national and international Notified Bodies and other international regulatory and Competent Authorities.
We are constantly developing new side services such as – among others – PMCF studies and real-world data collection, clinical development plan, Technical File full maintenance (e-TF, TF update) and PMS update.

Dedication

in 1MED we follow a client-centric business approach, giving all clients and all projects the attention they deserve. In this context, a positive work atmoshpere, a teamworking spirit, a consistent motivation and a professional work ethic are the distinct traits of our Company, which drive us to succeed in all the projects we are involved in.

Quality

in 1MED we strongly believe that quality is the backbone of our Company and our distinctive feature. The quality of our work, and of the documentation we provide, is perceptible both by the form and by the contents, reflecting the strong expertise of our team. We leave nothing to chance, and that’s why our work is often complimented by our clients and by Notified Bodies. To further confirm the quality of the services we provide, 1MED is an ISO 13485:2016 certified Company by TÜV Rheinland Italia.

Transparency

in 1MED we are always clear and transparent with our clients on each project’s feasibility. Depending on the type of product, on client’s needs and peculiar issues, we offer various viable ways for resolution, making each proposed strategy easily understandable to our clients. We lay out risks and benefits for each proposed route, in a clear and easy way. Also, being transparent about a clinical or regulatory project’s costs has allowed us to gain the trusts of our clients over time.

Scalable Approach

a scalable approach is the main value that has driven 1MED to the Company it is today, allowing it to preserve its efficiency as the size of the Company increased.
We apply the same approach to our clients’ projects, so that we ensure a proper pathway to success without missing any important step reflecting regulatory requirements. By adopting a scalable approach, we make your project sustainable.

Flexibility

in 1MED we follow a case-by-case approach, managing each project in a tailored fashion, thus still providing solutions that fit to clients’ needs for timelines and budget goals. While providing such a flexible service, we ensure efficient but shorter lines of communication with all the actors involved in the process, such as Notified Bodies and Competent Authorities.

Proactivity

1MED is a stable but dynamic Company. We train our employees to always be proactive and responsive, constantly delivering top results for your regulatory and clinical projects.

Dedication

In 1MED we follow a client-centric business approach, giving all clients and all projects the attention they deserve. In this context, a positive work atmoshpere, a teamworking spirit, a consistent motivation and a professional work ethic are the distinct traits of our Company, which drive us to succeed in all the projects we are involved in.

Quality

In 1MED we strongly believe that quality is the backbone of our Company and our distinctive feature. The quality of our work, and of the documentation we provide, is perceptible both by the form and by the contents, reflecting the strong expertise of our team. We leave nothing to chance, and that’s why our work is often complimented by our clients and by Notified Bodies. To further confirm the quality of the services we provide, 1MED is an ISO 13485:2016 certified Company by TÜV Rheinland Italia.

Transparency

In 1MED we are always clear and transparent with our clients on each project’s feasibility. Depending on the type of product, on client’s needs and peculiar issues, we offer various viable ways for resolution, making each proposed strategy easily understandable to our clients. We lay out risks and benefits for each proposed route, in a clear and easy way. Also, being transparent about a clinical or regulatory project’s costs has allowed us to gain the trusts of our clients over time.

Scalable Approach

A scalable approach is the main value that has driven 1MED to the Company it is today, allowing it to preserve its efficiency as the size of the Company increased.
We apply the same approach to our clients’ projects, so that we ensure a proper pathway to success without missing any important step reflecting regulatory requirements. By adopting a scalable approach, we make your project sustainable.

Flexibility

In 1MED we follow a case-by-case approach, managing each project in a tailored fashion, thus still providing solutions that fit to clients’ needs for timelines and budget goals. While providing such a flexible service, we ensure efficient but shorter lines of communication with all the actors involved in the process, such as Notified Bodies and Competent Authorities.


Proactivity

1MED is a stable but dynamic Company. We train our employees to always be proactive and responsive, constantly delivering top results for your regulatory and clinical projects.

1MED follows a client-centric business approach aimed at providing tailor made turn-key solutions.
In today’s competitive market, the time needed to reach product’s approval is critical for a Company’s success. The proper conduct of regulatory and clinical activities is therefore of considerable strategic and economic importance.

In this current scenario, 1MED provides high-quality customized and scalable CRO solutions for regulatory compliance and clinical study management, fitting both regulatory requirements and client’s needs, minimizing project chances of failure and unwanted extra costs.

1MED not only offers a broad range of internal competences: our clients can also rely on a preferred partners network and consolidated relationships with European Notified Bodies, Competent Authorities, Research Hospitals and Clinical Institutes.

Mission

In 1MED we are devoted to support clients’ innovative products and technologies development, in order for patients to have quick but safe access to cutting edge therapies.
We assist manufacturers with products’ approvals, clinical trials management and we also offer support in the post-market phase to maintain quality and regulatory compliance. We take care of every single aspect of each project we follow, with a clear commitment to safety and ethics.

Our team

1MED boasts a multi-disciplinary team with expertise in design, engineering and certification of medical devices, combination products (drug-device) and in vitro diagnostics.
Thanks to a combination of high level expertise and staff with field experience, 1MED integrated solutions have been proved effective for well-regarded MedTech and Pharmaceutical Companies.

REGULATION (EU) 2017/745

REGULATION (EU) 2017/745