1MED
Contract research and regulatory services organisation focused on medical devices, IVDs and combination products. Provides regulatory strategy and dossier support for EU and US pathways, ISO 13485-aligned quality systems, clinical development and trial management (from first-in-human to registries and Phase I–IV), post-market surveillance and PMCF programs, and deployment of validated clinical-grade digital platforms for PMCF and real-world evidence.
Industries
Nr. of Employees
medium (51-250)
Products
Clinical-grade validated digital platform for PMCF and RWE
Validated digital platform engineered to generate regulator-ready post-market clinical evidence; aligns study design with ISO 14155, provides validated workflows, data traceability, timestamping and immutable audit trails for datasets and signatures.
Clinical-grade validated digital platform for PMCF and RWE
Validated digital platform engineered to generate regulator-ready post-market clinical evidence; aligns study design with ISO 14155, provides validated workflows, data traceability, timestamping and immutable audit trails for datasets and signatures.
Services
Regulatory strategy, technical documentation preparation, clinical evaluation, Notified Body liaison, and EU/US submission support.
Design, implementation and maintenance of ISO 13485-aligned QMS, internal audits, supplier qualification and support for conformity assessments.
End-to-end clinical trial services including protocol design, monitoring, site management, data management, biostatistics, medical writing and project management from first-in-human to registries.
PMS system optimisation, development of PMS plans, PMCF studies and reporting, PSUR preparation and vigilance follow-up.
Deployment, configuration and managed data collection using a validated clinical-grade digital platform to generate traceable and regulator-ready post-market clinical data.
Clinical development services including regulatory planning, monitoring, DSMB/CEC support and clinical quality assurance for combination products and therapeutics.
Regulatory strategy, technical documentation preparation, clinical evaluation, Notified Body liaison, and EU/US submission support.
Design, implementation and maintenance of ISO 13485-aligned QMS, internal audits, supplier qualification and support for conformity assessments.
End-to-end clinical trial services including protocol design, monitoring, site management, data management, biostatistics, medical writing and project management from first-in-human to registries.
PMS system optimisation, development of PMS plans, PMCF studies and reporting, PSUR preparation and vigilance follow-up.
Deployment, configuration and managed data collection using a validated clinical-grade digital platform to generate traceable and regulator-ready post-market clinical data.
Clinical development services including regulatory planning, monitoring, DSMB/CEC support and clinical quality assurance for combination products and therapeutics.
Expertise Areas
- Clinical trial management for medical devices, IVDs and combination products
- Post-market surveillance and PMCF program design and execution
- Regulatory strategy and dossier preparation for MDR/IVDR and FDA pathways
- Quality management system design and ISO 13485 implementation
Key Technologies
- Validated clinical data capture platforms
- Blockchain/timestamp-based data notarization
- AI-driven data quality monitoring
- ISO 14155-compliant clinical workflows
News & Updates
Announcement of a validated clinical-grade digital platform purpose-built for PMCF and real-world evidence with embedded regulatory compliance and immutable records.
Overview of ISO 10993-1:2025 changes and the role of gap analysis in biological evaluation strategies.
Webinar covering practical, risk-based strategies for building compliant and defensible PMCF programs under EU MDR and Notified Body expectations.
Webinar examining MDR and ISO 14155 requirements for clinical data, common conformity assessment non-conformities, data provenance and traceability, and the use of purpose-built digital infrastructures for defensible PMCF and RWE.
Company states management of over 170 clinical studies internationally.
Company cites supporting 500+ CE marked medical devices.
Announcement of a validated clinical-grade digital platform purpose-built for PMCF and real-world evidence with embedded regulatory compliance and immutable records.
Overview of ISO 10993-1:2025 changes and the role of gap analysis in biological evaluation strategies.
Webinar covering practical, risk-based strategies for building compliant and defensible PMCF programs under EU MDR and Notified Body expectations.
Webinar examining MDR and ISO 14155 requirements for clinical data, common conformity assessment non-conformities, data provenance and traceability, and the use of purpose-built digital infrastructures for defensible PMCF and RWE.
Company states management of over 170 clinical studies internationally.
Company cites supporting 500+ CE marked medical devices.