1MED is your MedTech partner providing Quality, Clinical and Regulatory support
with a quick practical but structured approach focused on deliverables.
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 approval authorities and Medicinal Agencies.
1MED is your MedTech partner providing Quality, Clinical and Regulatory support
with a quick practical but structured approach focused on deliverables.
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 approval authorities and Medicinal Agencies.
Why Choosing
1med
We provide an undivided attention that larger consultancy Companies and CROs cannot.
We are a Regulatory and Quality consultancy Company, but we are also a full service Contract Research Organization, so we can support your 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.
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.
Why Choosing
1med
We provide an undivided attention that larger consultancy Companies and CROs cannot.
We are a Regulatory and Quality consultancy Company, but we are also a full service Contract Research Organization, so we can support your throughout all your product’s lifecycle and for all necessary regulatory and clinical activities for pre-market to post-market compliance.
We always ensure transparent costs and reliable timelines.
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.
1MED provides services in the following fields.
Quality assurance
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.
Detail Services:
- ISO 13485
- FDA 21 CFR part 820
Regulatory Support
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.
Detail Services:
- Gap Analysis
- MDR expert support
- IVDR expert support
- Regulatory strategy for CE mark and FDA approval
- Notified Body selection and liaison
- Technical documentation review and preparation, including Clinical Evaluation according to MEDDEV 2.7.1
- Post Market Surveillance (PMS), including Post Market Clinical Follow-up (PMCF) and Post Market Vigilance (PMV)
- Support in the completion of Design History File (DHF) and Device Master Record (DMR)
- CTD for combination products
- Device and food supplement registration
- Product Information File (PIF) for cosmetics
Pre-clinical and Clinical
1MED supports its clients in defining the proper preclinical pathway to assess medical devices’ safety and performance features. 1MED also offers 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.
Detail Services:
- Clinical study design
- Site(s) election
- Study Start-Up
- Clinical Project Management
- Medical writing and preparation of study documentation as per ISO 14155
- eTMF
- Support for the Investigational Medicinal Product Dossier (IMPD)
- Biostatistics, data management and CRF/e-CRF
- Monitoring visits
- Real-World Evidence (RWE) registries
- Rescue studies
1MED provides services in the following fields.
Quality assurance
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.
Detail services:
- ISO 13485
- FDA 21 CFR part 820
Regulatory Support
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.
Detail services:
- ISO 13485
- FDA 21 CFR part 820
Pre-clinical and Clinical
1MED supports its clients in defining the proper preclinical pathway to assess medical devices’ safety and performance features. 1MED also offers 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.
Detail services:
- Clinical study design
- Site(s) election
- Study Start-Up
- Clinical Project Management
- Medical writing and preparation of study documentation as per ISO 14155
- eTMF
- Support for the Investigational Medicinal Product Dossier (IMPD)
- Biostatistics, data management and CRF/e-CRF
- Monitoring visits
- Real-World Evidence (RWE) registries
- Rescue studies
Now that the MDR transition period is about to end, we can support you reaching your MDR compliance. We can provide support for most of the regulatory, clinical and quality activities required for MDR and MDD.
Now that the MDR transition period is about to end, we can support you reaching your MDR compliance. We can provide support for most of the regulatory, clinical and quality activities required for MDR and MDD.
EU REGULATION 2017/745 (MDR)
EU REGULATION 2017/745 (MDR)
Contact Us
Telephone:
+41 (0)91 60 54 050
Where we are:
1MED SA
Via Campagna 13 – 6982 Agno
Switzerland