1MED
1MED is a global Contract Research Organization providing high-quality regulatory, clinical, and post-market services for medical devices, pharmaceuticals, and biotech companies. Established in 2014 and headquartered in Agno, Switzerland, it specializes in supporting innovative medical device development, ensuring compliance with MDR and IVDR regulations, and facilitating product certification and market access. With a focus on innovation, reliability, and comprehensive support across all phases of product lifecycle, 1MED aims to transform complex regulatory processes into efficient pathways for medical technology commercialization.
Industries
Nr. of Employees
small (1-50)
Products
Compliance assessment toolkit for MDR recertification
A structured assessment toolkit to identify documentation gaps and support preparation of submissions to notified bodies for MDR recertification.
Real-world data collection platform
A web-based tool for generation and digital implementation of questionnaires and registries to collect patient, professional user and economic operator data for PMS and recertification.
Compliance assessment toolkit for MDR recertification
A structured assessment toolkit to identify documentation gaps and support preparation of submissions to notified bodies for MDR recertification.
Real-world data collection platform
A web-based tool for generation and digital implementation of questionnaires and registries to collect patient, professional user and economic operator data for PMS and recertification.
Services
Clinical CRO services for MedTech
End-to-end clinical development services for medical devices including protocol design, study start-up, monitoring (on-site and remote), eTMF/CTMS support, site/investigator management, and post-market clinical programs.
Clinical CRO services for Biotech & Pharma
Full-service clinical development support for biotech and pharmaceutical sponsors across Phase I–IV including study start-up, patient recruitment, monitoring, data management, medical writing and biostatistics.
Regulatory consulting and submission support
Regulatory strategy, preparation of technical documentation, clinical evaluations, interaction with notified bodies and support for CE marking and MDR/IVDR compliance.
Quality services and ISO 13485 implementation
Design and implementation of quality management systems, QMS gap analyses, and procedures to obtain and maintain ISO 13485 certification.
Preclinical strategy and experimental protocol development
Definition of preclinical strategies and tailored experimental protocols to generate non-clinical evidence required for regulatory submissions.
Post-market support and surveillance
Post-market activities including PMS/PMCF planning and execution, vigilance reporting, post-market clinical follow-up and real-world evidence programs to maintain certification.
Clinical CRO services for MedTech
End-to-end clinical development services for medical devices including protocol design, study start-up, monitoring (on-site and remote), eTMF/CTMS support, site/investigator management, and post-market clinical programs.
Clinical CRO services for Biotech & Pharma
Full-service clinical development support for biotech and pharmaceutical sponsors across Phase I–IV including study start-up, patient recruitment, monitoring, data management, medical writing and biostatistics.
Regulatory consulting and submission support
Regulatory strategy, preparation of technical documentation, clinical evaluations, interaction with notified bodies and support for CE marking and MDR/IVDR compliance.
Quality services and ISO 13485 implementation
Design and implementation of quality management systems, QMS gap analyses, and procedures to obtain and maintain ISO 13485 certification.
Preclinical strategy and experimental protocol development
Definition of preclinical strategies and tailored experimental protocols to generate non-clinical evidence required for regulatory submissions.
Post-market support and surveillance
Post-market activities including PMS/PMCF planning and execution, vigilance reporting, post-market clinical follow-up and real-world evidence programs to maintain certification.
Expertise Areas
- Clinical trial management (FIH to Phase IV and registries)
- Medical device regulatory compliance (MDR/IVDR and CE marking)
- Post-market surveillance and PMCF programs
- Real-world evidence (RWE) and registry development
Key Technologies
- Real-world data (RWD) collection platforms
- eClinical systems (eTMF, CTMS, eCRF)
- Remote monitoring and decentralized trial tools
- Biostatistical analysis and statistical programming