What 1MED does

1MED SA is a Swiss-headquartered specialty Contract Research Organization (CRO) focused exclusively on MedTech devices, combination products, and in vitro diagnostics. Founded in 2014 and based in Agno, Switzerland, the firm operates with 11-50 employees and holds ISO 13485 certification. Its core customer base consists of European MedTech companies seeking regulatory approval, clinical evaluation, and post-market evidence generation under EU MDR and IVDR frameworks. The company's stated differentiator is its cross-functional model that integrates regulatory consultancy, quality management systems, clinical trial management, biometrics, medical writing, and digital evidence collection under one roof.

The company's flagship technology is 1Survey+, a clinical-grade digital platform purpose-built for Post-Market Clinical Follow-Up (PMCF) and Real-World Evidence (RWE) generation. 1Survey+ embeds EU MDR standards and ISO 14155 expectations directly into the data capture workflow, uses real-time blockchain validation for data integrity, and integrates AI agents for quality monitoring. This positions 1Survey+ as a productized, recurring-revenue layer on top of 1MED's professional services base, with the stated goal of producing 'Level-4 evidence' that is audit-ready for Notified Body review. The company has publicly emphasized the platform's distinction from traditional eClinical tools by framing compliance as native to the data collection process rather than retrofitted.

Commercially, 1MED generates revenue through a mix of professional services (CRO, regulatory, quality, post-market) and subscription-based digital solutions (1Survey+). Pricing is quote-based with no publicly disclosed tiers, consistent with an enterprise B2B sales motion. The go-to-market is sales-led and content-driven, relying on direct outreach, the 'Request Proposal' website funnel, educational webinars (including co-hosted sessions with TÜV), and thought leadership content targeting European regulatory and clinical stakeholders. Geographic focus is explicitly Europe-centric with claims of 'Europe and beyond' reach, though no international offices beyond Agno are disclosed.

Name

1MED

Legal name

1MED SA

Website

https://1med.ch

Company type

Private

Founded year

2014

Operating status

Operating

Headcount range

11–50 employees

Short description

1MED SA is a Swiss specialty CRO serving European MedTech, combination product, and IVD companies with regulatory, quality, clinical trial, and post-market services, complemented by its proprietary 1Survey+ clinical-grade digital evidence platform.

Ownership category

akta.pro rank

Product category

Medical Device CRO Services

NAICS

Research and Development in the Physical, Engineering, and Life Sciences (54171), Scientific Research and Development Services (5417)

SIC

Services-Commercial Physical & Biological Research (8731), Services-Prepackaged Software (7372)

akta.pro primary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

akta.pro secondary industries

Clinical Trial Informatics (EDC/CTMS/eCOA/eTMF) (HLAGAJAM), Clinical Site Start-Up & Activation (Regulatory/Ethics/Contracts) (HLAGACAC)

Keywords

• Clinical research services
• Medical device CRO
• Regulatory compliance consulting
• Post-market surveillance
• Clinical evidence generation

Headquarters

HQ city

Agno

HQ country

Switzerland

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Marketing or Sales, Infrastructure

Revenue model

1. CRO Services: Full-service CRO offerings including clinical trial management, regulatory consultancy, quality management systems, clinical studies support across all phases. Services cover MedTech industry, combination products, and in vitro diagnostics.
2. Digital Solutions (1Survey+): SaaS platform for clinical-grade data collection and evidence generation. The platform supports PMCF, PMS, RWE, and technical documentation updates, providing a validated digital process for regulatory compliance.
3. Regulatory Services: Technical Documentation and Clinical Evaluations compliant with MDR and IVDR, regulatory consultancy for product development.
4. Quality Services: Implementation of Quality Management Systems meeting ISO 13485 standards, post-market services, and quality compliance support.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels5 records

Core offering

1MED is a full-service Contract Research Organization (CRO) specialized in MedTech and combination products. It delivers clinical research, regulatory affairs, quality management, clinical trial management, pre- and post-market trial support, biometrics, and medical writing services across Europe and beyond. Its flagship 1Survey+ platform is a clinical-grade digital tool purpose-built for Post-Market Clinical Follow-Up (PMCF) and Real-World Evidence generation, embedding EU MDR standards, ISO 14155 expectations, blockchain-based data integrity, and AI-driven quality monitoring into a single validated workflow.

Product overview

1MED operates as a specialty MedTech and combination product CRO offering a unified portfolio of regulatory, quality, clinical, and digital services. The primary digital product is 1Survey+, a clinical-grade platform for PMCF and Real-World Evidence that serves as the company's flagship technology offering. This platform is complemented by a suite of services including Regulatory Services, Quality Services, CRO Services for MedTech industry, Post-Market Services, CRO Services for Combination Products, and Digital Solutions. The company is ISO 13485 certified.

Differentiator

Problem solved

Functional benefit

Brands

• 1Survey+: The first clinical-grade platform for PMCF and Real-World Evidence. Engineered to meet MDR standards, designed to generate Level-4 evidence, aligning clinical methodology, ISO 14155 expectations, and real-time data integrity into a single validated process.

Products and services

• CRO Services for the MedTech Industry

Quantifiable outcome

• Level-4 evidence generation capability through 1Survey+ platform

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

One partnership is on record.

• TÜVcoreStrategic or Co-development Partner1MED co-hosts webinars with TÜV experts on topics such as data quality and reliability in clinical trials and PMCF under MDR. TÜV provides regulatory expertise and credibility as a Notified Body, while 1MED contributes clinical and digital solutions knowledge. The collaboration addresses shared audience interest in MDR compliance and audit preparation.

Scale indicators2 records

Recent moves5 records

Expansion highlights5 records

Direct peers

• NAMSA: NAMSA is the largest specialty MedTech-focused CRO globally, offering preclinical, clinical, regulatory, and quality services for medical device manufacturers. It is the most directly comparable peer given overlapping MedTech CRO service lines, ISO 13485-aligned operations, and similar combination product expertise.
• RQM+: RQM+ is a MedTech-focused regulatory and quality consultancy and CRO serving device manufacturers with MDR/IVDR transition, clinical evaluation, and post-market services. Closely comparable to 1MED's combination of regulatory consultancy and clinical trial support for MedTech clients.
• Qserve Group: Qserve Group is a European-based MedTech regulatory affairs, clinical, and quality consultancy operating across the MDR/IVDR space. Directly comparable due to similar geographic positioning (Europe), MedTech specialization, and overlap in regulatory consultancy plus clinical evidence services.
• Maetrics: Maetrics provides MedTech regulatory, quality, and clinical compliance consulting with deep ISO 13485 and MDR expertise. Comparable niche-focused CRO/consultancy serving device manufacturers in the same regulatory-driven buying cycle as 1MED.

Broad incumbents

• TÜV SÜD: TÜV SÜD is a major global Notified Body and testing/certification organization actively expanding MedTech clinical and consultancy services. Already a confirmed partner of 1MED, it represents both a collaboration channel and a broader incumbent competitor with vastly greater geographic and operational scale.
• BSI Group: BSI is a major Notified Body and standards organization that has expanded its MedTech clinical and regulatory services portfolio. Comparable as a large European incumbent serving device manufacturers navigating MDR/IVDR compliance with broader service breadth than 1MED.
• IQVIA: IQVIA is the largest global CRO with a dedicated MedTech practice serving large device OEMs across clinical, regulatory, and real-world evidence services. Represents the broad incumbent 1MED competes against for enterprise MedTech sponsors seeking global, multi-vendor consolidation.
• ICON plc: ICON plc is a global CRO with an active MedTech division offering clinical, regulatory, and post-market services. Comparable as a broad incumbent competing for the same MedTech sponsor wallet with substantially greater scale and geographic reach.

Emerging players

• Medrio: Medrio provides EDC and eClinical software for clinical trials with growing focus on MedTech and post-market studies. Comparable to 1Survey+ as a clinical trial technology platform, though Medrio is more generalist and not specifically engineered for MDR/PMCF workflows.
• Castor: Castor is a clinical trial platform providing EDC, ePRO, and eCOA capabilities with growing MedTech and decentralized trial adoption. Comparable to 1Survey+ as an emerging eClinical platform player, though without the MDR-specific data validation and quality monitoring features.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about 1MED