Specialty MedTech and combination product CRO

1MED offers clinical and regulatory support, quality management, clinical trial management, pre and post market trial support, biometrics, medical writing and digital solutions across the clinical research continuum with a cross-functional approach.

At 1MED we are dedicated to continuous growth and excellence.

1MED dedicated to advancing science, together

1MED offers clinical and regulatory support, quality management, clinical trial management, pre and post market trial support, biometrics, medical writing and digital solutions across the clinical research continuum with a cross-functional approach.

As a specialty MedTech CRO our commitment to innovation drives us to constantly evolve and strengthen our capabilities. By embracing innovative technologies and methodologies, we offer comprehensive, cutting-edge solutions designed to meet the unique challenges of our clients. This dedication ensures a reliable and trusted partner, committed to advancing science, together.

The new standard for Clinical Data collection

1Survey+
The first clinical-grade platform for PMCF and Real-World Evidence

Engineered to meet MDR standards

1Survey+ was built to generate Level-4 evidence, aligning clinical methodology, ISO 14155 expectations, and real-time data integrity into a single validated process.
Designed under clinical and regulatory supervision Include sample sizing, validated tools, traceability, and integrity checks Appropriate for PMCF, PMS, RWE, and technical documentation updates.

1MED at
RAPS Euro Convergence 2026

Join us in Lisbon from May 5th to 8th! We will be waiting for you at Booth 33. On May 7th, Enrico Perfler and Christine Beulshausen will lead a presentation titled:
'How to ensure data quality and reliability in clinical trials and PMCF under MDR'.

Book a meeting with us through our Contact Us form!

PMCF Under MDR
Generating Robust and Defensible Post-Market Clinical Evidence

Join our webinar to learn how to generate robust and defensible PMCF evidence to ensure MDR compliance.

The new standard for Clinical Data collection

1MED Launches 1Survey+: The First Clinical-grade Platform Purpose-built for Post-Market Clinical Follow Up.

1Survey+ transforms every dataset, signature, and action into a compliant, immutable record. Unlike traditional tools, we embed EU MDR standards directly into the workflow, securing your data with real-time blockchain validation. With integrated AI agents to monitor quality, 1Survey+ provides a unified platform where sponsors and CROs generate evidence that is transparent, audit-ready, and trusted by regulators.

Solutions

We are a CRO committed to ensuring the success of your projects by providing holistic guidance on product development, starting with the implementation of Quality Management Systems meeting ISO 13485 standards, regulatory consultancy for Technical Documentation and Clinical Evaluations compliant with MDR and IVDR, and comprehensive support for clinical studies across all phases in Europe and beyond.

Regulatory Services

Quality Services

CRO Services for the MedTech industry

Post-Market Services

Digital Solutions

CRO Services for Combination Products

Why us

As a Clinical Research Organization (CRO) dedicated to serving MedTech and combination product developers. We tackle your challenges as our own, accelerating the regulatory and commercial processes of your medical devices, combination products, and in vitro diagnostics. As an ISO 13485 certified company, we blend reliability with the agility of a start-up, offering regulatory support, digital solutions, and full-service CRO services