About us


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 extensive 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 and pharmaceutical products.


What you want. What you need. How to get there.

1MED is a full service CRO that aims to take your drug or device to market, no matter the starting point.

The development of new drugs and medical devices involves several partners across multiple disciplines. 1MED is uniquely qualified to meet client’s needs and expectations in the current environment. We know what is needed for each step, what will be needed next, and who to work together with to get you there. Our speciality tailored services meet your specific objectives and streamlines your project’s progress. We run an efficient operation, with the highest degree of responsiveness and accountability, thereby minimizing project failure and client costs.

1MED offers services in:

  • Regulatory affairs
  • Regulatory intelligence
  • Medical Device CE Marking Strategy
  • Pre-clinical product development
  • Clinical study feasibility
  • Full service clinical study management
  • Project management
  • Post market surveillance
  • Biometrics (data management, statistical analysis & programming)
  • Quality assurance
  • Post Market Clinical Follow-Up (PMCF)
  • Real-World Evidence (RWE) studies

Service


Regulatory

We ensure compliance, always

A well-designed regulatory strategy considers not only European and international regulations, but also development costs, development cycles, and profitability concerns. We work side-by-side with you to design and implement a competitive and cost-effective regulatory strategy, prepare and submit a reviewer-friendly technical documentation, assist you in negotiating with national and international notified bodies, FDA, and international regulatory agencies quickly and effectively.

We provide deep sector and regulatory expertise at all stages in your drug or medical device lifecycle, from pre-clinical assessment to clinical trials, CE marking and post market surveillance.

Our regulatory team is composed of specialists and consultants with years of experience in all phases of product development, thus and that have participated in international regulatory technical committees. This enables us to have a holisitic and unmatched approach to advising our clients on how to best develop and implement there regulatory strategy to achieve product approval.

1MED therefore meets even the most exacting standards of international regulatory agencies, maximizing the cost-effective use of your company’s resources and anticipating potential regulatory issues.

Our turnkey service:
  • Regulatory assistance and strategies for CE marking and FDA approval
  • Regulatory plan & gap analysis
  • Preparation of a full technical file/design dossier
  • Risk assessment (ISO 14971)
  • Device registration
  • CAPA support
  • Quality strategy, maintenance and certification (ISO 9001, ISO 13485)
  • Medical devices post-market surveillance plan
  • Post market clinical follow-up
  • Post market performance follow-up
  • Labelling – product leaflets and instructions for use review
  • Regulatory and quality training
  • Third party regulatory compliance

Pre-clinical & clinical

Nothing is left to chance
Repeatable. Reliable. Results.

The regulatory approval of drugs and devices is conditional on repeatable and reliable results. 1MED offers clinical research services & solutions for all your clinical trials needs. We manage and oversee all phases of clinical trials with the utmost care and consideration for the patient. Our connections in this industry allow us to find the most suitable fit for your research and testing needs. This allows us to be flexible with emerging trends in submission procedures and to ensure compliance with all local and international regulatory requirements.

At 1MED we understand that planning and site selection is the key to a successful trial. Our in-depth knowledge about regulatory and clinical trials requirements in every country, ensures a global trial will move rapidly and results in shorter timelines to expedite market access.

  • Pre-market and post market clinical trial support of study design, management and execution
  •  
  • Clinical study protocol development
  •  
  • Clinical site selection, contracting, qualification, management and training
  • Site monitoring visits
  • Biostatistics, data management and eCRF support
  • Final study report
  • Study documentation preparation / review:
    • Trial master file
    • Investigator’s brochure
    • Patient information & consent forms
    • Clinical Trial Application (CTA)
    • Investigational Medicinal Product Dossier (IMPD)

Your full service cro for medical product development


1MED is renowned for its specialty in medical device design, development and validation, whilst retaining in-house experience and contacts to support pharmaceutical product development. Our familiarity with regulatory variations and industry trends maintains our approach to device development current and forward-looking.

The scientific principles upon which a device is based are fundamental to its safety and performance. The more complex the device, the higher risk of user error. Soundness of concept and adequacy of design, manufacture, and testing, including verification, validation and clinical trials, require the scrutiny of scientific experts to ensure that design parameters and performance characteristics do not impose unwarranted risks on the end user.

1MED has a full range of competences in the medtech industry

Services and support for:
  • Investor’s due diligence assessment
  •  
  • Medical device feasibility analysis
  •  
  • Gap analysis & regulatory strategy plan
  • Design of preclinical studies (ex-vivo & in vivo)
  • Device design and development plan
  • Identification of laboratories for test and validations

PRE-CLINICAL STUDIES

1MED is your proactive collaborative CRO partner and looks to save you time and resources through the pre-clinical and clinical phases. Our strategic partnership with 1LAB provides you with reliable and viable clinical evidence on the feasibility of your ideas. 1LAB is a specialized laboratory in advanced pre-clinical in vitro testing which uses biomaterial scaffolding and tissue engineering technology to replicate human vessels, skin, and mucosa. 1LAB’s multidisciplinary approach is scientifically backed and is equipped with highly trained staff and with robust industry experience.  Our 1LAB partnership gives us a powerful tool in generating reliable and replicable high-quality data in preparation for clinical trials.

Mission


Bringing innovative
medical technologies
to market

YOUR PROACTIVE FULL SERVICE CRO PARTNER

1MED is devoted to support its clients throughout the entire lifecycle of their medical products, managing life science innovation from bench to bed and maximizing the cost-effective use of client’s resources in achieving its goals. We aim for customer satisfaction and obtain it with perseverance, competence, dedication, focus and attention for the details. Our mission is to bring your new and innovative drugs and medical devices from bench to market byunderstanding industry leading practices and the competitive environment market. Thanks to our pragmatic approach in problem solving, team working attitude, and experience with a wide range of medical device products we ensure the success of your project.

At 1MED we don´t just listen to what you want, we use our expertise to determine what else you need on the path to your product´s regulatory approval. This proactive CRO service approach has helped us provide better solutions to clients, maximizing the cost-effective use of their company’s resources in achieving their goals.

How we can help you

The drug and device development world is a highly competitive market, where time is of essence. Any reduction in time needed to reach regulatory approval gives companies an edge over competitors. Thus, working with 1MED, a CRO that knows the ins and outs of pre-clinical and clinical research, development, and regulatory affairs, is of considerable strategic and economic benefit to your company. We stay up-to-date with leading industry practices, ISO standards, and regulatory changes from the European Medical Device Regulation (MDR). We also monitor developing regulatory trends to assist you at every stage of your drug or device life cycle.

1MED is a young company, founded in 2015, yet due to its knowledgeable team of experienced professionals, has consolidated and a proven track record experience in the life sciences. Our experience at 1MED in successful planning, clinical testing, regulatory approval, and bringing products to market, equips us with the skills and knowledge to properly advise you and help you achieve success. We can save you time, and therefore money, during the approval process for your medical device due to our predictable and stable costs. We handle a diverse array of projects in the medical device industry and offer support for all regulatory compliance issues worldwide.

The repeat, long-term and diverse clientele we support speaks for itself; we are an added value to your company.

We are not just another CRO, we are your collaborative proactive partner.

Team

1MED is composed of a multi-disciplinary team with a consolidated background in Medical Device Technology and proven expertise in Medical Device Development and Testing, Regulatory Affairs Quality Assurance, Product and Company Certification, and Clinical Trials Management.

Fully
Bespoke
Outsorced
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. 

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.

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.

Device &
Pharmaceutical
Procuct
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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