1MED is your Contract Research Organization for clinical and regulatory development.
Our services cover a product’s entire lifecycle, from design and development, to certification in Europe or approval in the United States. We can also support you through the post-market life of your product.
Thanks to our experienced, multidisciplinary and highly specialized team, we can deal effectively with Competent Authorities, Notified Bodies and Regulatory Agencies.
1MED is your Contract Research Organization for clinical and regulatory development.
Our services cover a product’s entire lifecycle, from design and development, to certification in Europe or approval in the United States. We can also support you through the post-market life of your product.
Thanks to our experienced, multidisciplinary and highly specialized team, we can deal effectively with Competent Authorities, Notified Bodies and Regulatory Agencies.
Why Choosing 1MED
1MED was established as a consultancy Company, with the primary aim of offering tailored regulatory and quality services to MedTech Companies.
With an increased understanding of the complexity of the medical devices’ market, 1MED has grown to become a full service Contract Research Organization, answering the more and more demanding requirements of the medical device regulations by providing smart and customized solutions to clients in the regulatory and clinical field. Thanks to an experienced and specialized multi-disciplinary team, with distinct technical skills, 1MED is able to speak the same technical-scientific language of its clients.
Why Choosing 1MED
1MED was established as a consultancy Company, with the primary aim of offering tailored regulatory and quality services to MedTech Companies.
With an increased understanding of the complexity of the medical devices’ market, 1MED has grown to become a full service Contract Research Organization, answering the more and more demanding requirements of the medical device regulations by providing smart and customized solutions to clients in the regulatory and clinical field. Thanks to an experienced and specialized multi-disciplinary team, with distinct technical skills, 1MED is able to speak the same technical-scientific language of its clients.
Our Company values
Dedication
Quality
Transparency
Scalable
Approach
Flexibility
Proactivity
Our Company values
Dedication
Quality
Transparency
Scalable Approach
Flexibility
Proactivity
Our Services
Regulatory
1MED provides deep sector and regulatory expertise at all stages of a product’s lifecycle, from preclinical assessment and clinical trials to CE marking and post-market surveillance. We offer our expertise to support our clients with EU or US regulatory or quality issues for all types of medical devices (class I, II and III), including combination products (drug-device) and IVDs.
We have an extensive experience in developing clinical evaluation reports and assisting our clients with clinical, biological and technical equivalence determination to define clinical data collection strategy, in the pre-market and post-market phase.
Quality
In order to bring products to the market, it is mandatory for manufacturers to have a Quality Management System (QMS) in place.
New MDR has formalized the expectations that your QMS documents, records, product information, risk, etc. are all connected together. In other words, all documentation and records of your QMS and products need to be a seamless system of data and information.
1MED can support you in making this requirement a reality in your Company, helping you creating a ISO 13485 QMS, implementing it and ensuring its maintenance.
Preclinical
1MED supports its clients in defining the proper preclinical pathway to assess medical devices’ safety and performance features. We can provide support for preclinical testing assessing your medical device’ safety and performance thanks to our strategic partnership with 1LAB.
Clinical
1MED is a full service CRO offering clinical research services and solutions for all clinical trials’ needs. Our in-depth knowledge of regulatory and clinical trials’ requirements across Countries, enables a smooth and fast market access, while ensuring regulatory compliance.
Our Services
Regulatory
1MED provides deep sector and regulatory expertise at all stages of a product’s lifecycle, from preclinical assessment and clinical trials to CE marking and post-market surveillance. We offer our expertise to support our clients with EU or US regulatory or quality issues for all types of medical devices (class I, II and III), including combination products (drug-device) and IVDs.
We have an extensive experience in developing clinical evaluation reports and assisting our clients with clinical, biological and technical equivalence determination to define clinical data collection strategy, in the pre-market and post-market phase.
Quality
In order to bring products to the market, it is mandatory for manufacturers to have a Quality Management System (QMS) in place.
New MDR has formalized the expectations that your QMS documents, records, product information, risk, etc. are all connected together. In other words, all documentation and records of your QMS and products need to be a seamless system of data and information.
1MED can support you in making this requirement a reality in your Company, helping you creating a ISO 13485 QMS, implementing it and ensuring its maintenance.
Preclinical
1MED supports its clients in defining the proper preclinical pathway to assess medical devices’ safety and performance features. We can provide support for preclinical testing assessing your medical device’ safety and performance thanks to our strategic partnership with 1LAB.
Clinical
1MED is a full service CRO offering clinical research services and solutions for all clinical trials’ needs. Our in-depth knowledge of regulatory and clinical trials’ requirements across Countries, enables a smooth and fast market access, while ensuring regulatory compliance.
Depending on your needs and on the product involved, we are able to select the right team for an optimal project management.
In 1MED we have a multi-disciplinary team with expertise in design, engineering and certification of medical devices, combination products and in vitro diagnostics. All team members have high scientific degrees in disciplines such as Genetics, Molecular and Cellular Biology, Medical Biotechnology, Pharmacy, Pharmaceutical Chemistry, Medicinal Chemistry and Technology, Biomedical Engineering, Statistics and Medicine.
Thanks to its solid reputation, international networking and a strong problem solving attitude of its team, 1MED is capable of dialoguing with EU and US regulatory agencies, supporting clients in all stages of their regulatory and clinical development program.
From a clinical perspective, 1MED has experience with all types of clinical trials, from First In Human to pivotal pre-market studies, from post-market clinical follow up activities to retrospective studies.
Our clinical and regulatory team members are highly specialized, and manage projects in multiple therapeutic areas, such as:
Cardiology/Cardiovascular
Hematology
Gastroenterology
Dermatology
Rheumatology
Ophthalmology
Dental and oral care
Aesthetic medicine
Gynecology
Proctology
Urology
ENT
Respiratory
Oncology
Cardiology/Cardiovascular
Hematology
Gastroenterology
Dermatology
Rheumatology
Ophthalmology
Dental and oral care
Aesthetic medicine
Gynecology
Proctology
Urology
ENT
Respiratory
Oncology
Competitive edge
We provide an undivided attention that larger consultancy Companies and CROs cannot.
We always ensure transparent costs and reliable timelines.
Thanks to our Regulatory Intelligence and to our regulatory and quality expertise, we are always updated on the global regulatory framework, so that we can anticipate future regulatory trends.
We have an excellent working relationship with KOL, Notified Bodies and Competent Authorities.
We are a Regulatory and Quality consultancy Company, but we are also a full service Contract Research Organization, so we can support you throughout all your product’s lifecycle and for all necessary regulatory and clinical activities for pre-market to post-market compliance.
We not only provide consultancy services, but we are also qualified by Notified Bodies to train Companies, to ensure clients’ employees are aware and properly aligned for regulatory compliance.
Competitive edge
We provide an undivided attention that larger consultancy Companies and CROs cannot.
We always ensure transparent costs and reliable timelines.
Thanks to our Regulatory Intelligence and to our regulatory and quality expertise, we are always updated on the global regulatory framework, so that we can anticipate future regulatory trends.
We have an excellent working relationship with KOL, Notified Bodies and Competent Authorities.
We are a Regulatory and Quality consultancy Company, but we are also a full service Contract Research Organization, so we can support you throughout all your product’s lifecycle and for all necessary regulatory and clinical activities for pre-market to post-market compliance.
We not only provide consultancy services, but we are also qualified by Notified Bodies to train Companies, to ensure clients’ employees are aware and properly aligned for regulatory compliance.
Certification
1MED is a Swiss-based, EN ISO 13485:2016, certified full service Contract Research Organization.
In 1MED we are setting an increasingly higher level of quality. Thanks to the continuous training of the regulatory and clinical team, we ensure awareness of the global regulatory framework and knowledge of future regulatory trends.
We have been appointed as selected partners for MDR, ISO 13485 and clinical evaluation trainings by the most important EU Notified Bodies!
Certification
1MED is a Swiss-based, EN ISO 13485:2016, certified full service Contract Research Organization.
In 1MED we are setting an increasingly higher level of quality. Thanks to the continuous training of the regulatory and clinical team, we ensure awareness of the global regulatory framework and knowledge of future regulatory trends.
We have been appointed as selected partners for MDR, ISO 13485 and clinical evaluation trainings by the most important EU Notified Bodies!
Now that the MDR transition period is about to end, we can support you reaching your MDR compliance. We can provide support for EU Medical Device Regulation and FDA
REGULATION (EU) 2017/745
News
1MED INNOVATION DIGITAL FORUM
Il 3 Luglio si è tenuto il primo 1MED INNOVATION DIGITAL FORUM, un incontro virtuale che ha permesso di approfondire temi di attualità relativi alla prossima applicazione del Nuovo Regolamento sui Dispositivi Medici (UE) 2017/745 e del Nuovo Regolamento sulla...
Clinical data and clinical evidence requirements under MDR: free Expert Guidance
Compared to the old Directives, the new Medical Device Regulation (MDR) reinforces important factors and provides additional requirements concerning the process of clinical evaluation. Since clinical evaluation has always been a major critical activity for medical...
26 MAY 2021: the new Date of Application of MDR
In order to prioritise focus of Member States, health institutions and economic operators on the fight against COVID-19 pandemic, the European Parliament and the Council has today approved to postpone the Date of Application (DoA) of the Medical Device Regulation (EU)...
Contact us
Telephone:
Where we are:
1MED sa
Via Campagna 13
6982 Agno
Switzerland
How to get there:
1MED office location:
– 1 Km from Lugano Airport (Agno)
– Less than 500 m from Serocca d’Agno train stop
– Less than 6 Km from Lugano train station