Agno, Switzerland – 27 January 2026 – 1MED, a Contract Research Organisation (CRO) specialised in MedTech, combination products and digital solutions today announced the launch of 1Survey+, the first clinical-grade platform purpose-built for post-market clinical follow-up (PMCF) and clinical data collection, designed in accordance with ISO 14155 requirements and enhanced with a blockchain-based audit layer guaranteeing verifiable data integrity.
Under the EU Medical Device Regulation (MDR), hundreds of thousands of class IIa, IIb and III medical devices placed on the European market are required to continuously generate post-market clinical evidence in order to maintain market access. This regulatory shift has transformed PMCF from a periodic obligation into a structural, long-term requirement, significantly increasing operational complexity, regulatory exposure and cost for manufacturers.
Enrico Perfler, Founder of 1MED commented: The objective behind 1Survey+ is to digitalise the generation of clinical evidence through a system that embeds quality controls, real-time validation, anti-manipulation safeguards and full auditability by design.1Survey+ was built to ensure that clinical data are reliable, traceable and defensible from the moment they are collected, not retrospectively fixed.
Generating clinical evidence that meets regulatory expectations requires a rigorous and structured approach to data collection. Compliance with ISO 14155, the MDR, MDCG guidance and EMA expectations for computerized systems is essential. However, existing digital survey and data-collection tools were not designed to meet these standards. As a result, PMCF activities, clinician feedback programmes and real-world evidence initiatives often produce datasets that are incomplete, non-verifiable or insufficient to support a robust clinical evaluation, leading to rework, audit findings and regulatory risk.
1Survey+ addresses these challenges through an integrated, regulator-ready solution that combines:
- a purpose-built digital platform designed specifically for high-quality, audit-ready clinical evidence generation.
- 1MED’s deep clinical, methodological and regulatory expertise, ensuring that every step of the process is scientifically sound, traceable and fully compliant with applicable regulations.
By embedding data quality controls and auditability directly at source, 1Survey+ significantly reduces manual reconciliation, remediation cycles and rework, lowering the total cost of post-market clinical compliance while strengthening regulatory confidence in the resulting evidence.
Janet Kube, CEO of 1MED commented: “The launch of 1Survey+ marks a major step forward for medical device manufacturers. By combining a purpose-built digital platform with 1MED’s clinical, regulatory, and statistical expertise, we enable the generation of high-quality evidence designed to withstand rigorous regulatory review.
One of the most exciting benefits of 1Survey+ is its potential to significantly reduce the financial pressures of post-market data collection – supporting manufacturers in keeping innovative and essential products available to the patients who rely on them.”
About 1MED
1MED, a Contract Research Organisation (CRO) specialised on MedTech, combination products and digital solutions.
Offering 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.
In the past 5 years 1Med has supported 500+ different medical devices with certification and shelf-life extension.
For more information visit, www.1med.net
Media Contact:
Joakim Lindroos
Tel: +41 (0)91605 40 50
Email: joakim.lindroos@1med.net
