1LAB SA is a company active in MedTech and clinical research. It provides clinical and regulatory support, quality management, clinical trial management, and digital solutions for medical devices and combination products.
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Industry:Medical Technology Industry
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Regulatory support for medical devices and in vitro diagnostics, including technical documentation, clinical assessments and MDR- and IVDR-compliant advice.
Quality management services
Implementation and ongoing support for quality management systems according to ISO 13485, including quality-related support for MedTech development projects.
CRO services for the MedTech industry
Support for clinical studies across all phases in Europe and beyond, with clinical, regulatory and biostatistical support as well as medical writing.
Post-market services
Support for PMCF, PMS and real-world evidence, as well as post-market trial support and technical documentation updates.
Digital solutions (1Survey+)
Digital platform for clinical data capture and PMCF, with validated tools, traceability, integrity checks and MDR-oriented evidence generation.
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