What Repado does

Repado is a privately held, ISO 13485:2016 and ISO 9001:2015 certified software development house founded in 2007, headquartered in Rapperswil, Switzerland, with a second office in Athens, Greece. The company specializes in regulated medical software for the MedTech, life sciences, and laboratory automation industries, developing products and services compliant with EU MDR/IVDR, FDA 21 CFR Part 820 and Part 11, IEC 62304 (safety classes A-C), ISO 14971, IEC 62366, and IEC 82304. With 11-50 employees and 20+ years of domain experience, Repado targets medical device manufacturers, IVD/OEM companies, hospitals, laboratories, and pharmaceutical companies across Europe, the United States, and other international markets.

Repado's product portfolio centers on three proprietary platforms: SWIS (a modular software platform for liquid handling instruments with Flow, Analyze, and Studio sub-modules), LTM Suite (an M2M medical device fleet management platform providing remote monitoring, diagnostics, and predictive maintenance), and SOLAR (a lab automation platform with modules for PCR setup, nucleic acid extraction, sample preparation, and assay reading). Additional products include CLEIS and CLEISplus for CLART-based diagnostic microarray reading, AUTRAX for nucleic acid extraction workstations, and OHLink for transboundary infectious disease surveillance. Products are commercialized via direct enterprise sales, OEM/whitelabel licensing (e.g., SWIS embedded in Certest Biotec's VIASURE V-Flex on Tecan's Cavro Magni-flex platform), and EU-funded research consortium participation (PREPARE-TID/Horizon Europe, H2020 MSCA, SiLA Consortium).

The business model combines project-based custom software development and regulatory affairs consulting (quote-based, covering EU MDR/IVDR and FDA submissions) with licensing of proprietary modular products. Pricing is fully custom and not publicly disclosed. Repado's go-to-market is direct B2B enterprise sales supplemented by industry conference presence (SLAS, MEDICA, AACC, ECCMID, Analytica, Arab Health), content marketing via its blog and LinkedIn, and EU research consortium channels. The company is led by CEO Kostas Delakouridis and has contributed to FDA 510(k)-cleared products (NU-RISE PRO-DOSE, November 2025) and CE-IVD-approved diagnostics (GENOMICA COVID-19 kits). No venture capital, private equity investment, or public listing is disclosed; growth appears bootstrapped and supplemented by EU research grants.

Name

Repado

Legal name

Repado

Website

https://repado.com

Company type

Private

Founded year

2007

Operating status

Operating

Headcount range

11–50 employees

Short description

Repado is an ISO 13485-certified Swiss-Greek software house that develops regulated medical software, proprietary lab automation platforms (SWIS, LTM Suite, SOLAR), and regulatory consulting services for MedTech manufacturers, IVD OEMs, and pharmaceutical companies in EU and US markets.

Ownership category

akta.pro rank

Product category

Medical Device Software

NAICS

Software Publishers (5132), Custom Computer Programming Services (541511), Analytical Laboratory Instrument Manufacturing (334516)

SIC

Services-Prepackaged Software (7372), Laboratory Analytical Instruments (3826)

akta.pro primary industry

Quality, Compliance & Validation Software for Labs (GxP/CSV, eQMS for QC Labs) (HLAGAJAI)

akta.pro secondary industries

Quality Engineering & Risk Management (ICH Q9/Q10, validation, change control) (HLAGAKAL), Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI)

Keywords

• Medical device software
• Lab automation software
• Regulatory affairs consulting
• Liquid handling software
• MedTech software development

Headquarters

HQ city

Rapperswil

HQ country

Switzerland

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Software

Cost components

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

Revenue model

1. Custom Software Development Services: Repado provides bespoke software development services for medical devices, embedded systems, SaMD, eHealth/mHealth applications, middleware, and ICT solutions for healthcare providers. Revenue is generated on a project-by-project basis, with engagements covering design, development, validation, and post-market support under regulated environments (MDR/IVDR, FDA). Services are priced quote-based.
2. Regulatory Affairs Consulting: Consultation services covering regulatory strategy, technical documentation (Design Dossiers, Technical Files), compliance testing, and audit readiness for EU MDR/IVDR and FDA 21 CFR Part 820 markets. Billed as part of project engagements or standalone consulting engagements.
3. Software Product Licensing (SWIS™, LTM, SOLAR): Proprietary modular software products (SWIS™, LTM Suite, SOLAR) commercialized as tailored solutions for the laboratory automation and liquid handling industry. These are sold as off-the-shelf or customized packages to OEMs and instrument manufacturers.
4. Quality Assurance / Testing Services: QA testing services for medical software covering full-cycle testing, usability testing (EN IEC 62366), and security testing (aligned with ANSI UL 2900-2-1, HIPAA, GDPR, FDA cybersecurity guidelines). Offered as a standalone service to complement software development.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels6 records

Core offering

Repado is an ISO 13485:2016 certified software development house that designs, develops, and licenses certified medical software for MedTech, life sciences, and laboratory automation customers. The company delivers both bespoke custom medical software (covering embedded control software, Software as a Medical Device, eHealth/mHealth, and middleware) and proprietary products (SWIS, LTM Suite, SOLAR, CLEIS, CLEISplus, AUTRAX, OHLink) commercialized as OEM/white-label solutions. It complements this with regulatory affairs consultation and QA testing services aligned with EU MDR/IVDR, FDA 21 CFR Part 820/Part 11, IEC 62304, ISO 14971, and IEC 62366 frameworks.

Product overview

Repado is a certified software development house offering a portfolio of proprietary products and professional services for the healthcare and life sciences industry. The core product offerings include: SWIS (modular software platform for liquid handling instruments with Flow, Analyze, and Studio modules), LTM Suite (medical device fleet management platform), and Solar Suite (lab automation platform with multiple workflow modules). Additional products include CLEIS and CLEISplus for CLART-based diagnostic reading, AUTRAX for nucleic acid extraction, and OHLink for infectious disease surveillance. Repado also provides Software Development and Regulatory Affairs Consultation services, plus QA Testing services for medical software. All products are developed under ISO 13485 certified quality management systems for regulated MDR/IVDR and FDA markets.

Differentiator

Problem solved

Functional benefit

Brands

• SWIS: Modular, compliance-ready software platform for liquid handling instruments with modules including SWIS Flow, SWIS Analyze, and SWIS Studio.
• LTM
• SOLAR
• AUTRAX
• CLEIS
• CLEISplus
• OHLink

Products and services

• SWIS SWIS is a modular, compliance-ready software platform for liquid handling instruments offering tailored solutions across complete workflows, including SWIS Flow (operational workflows with real-time execution monitoring), SWIS Analyze (automated data interpretation with configurable multi-marker logic and QC tracking), and SWIS Studio (no-code protocol configuration). It supports IVDR- and FDA-regulated environments with 21 CFR Part 11, GLP compliance, HL7 LIMS connectivity, and third-party device integration. Target customers: OEMs and instrument manufacturers in laboratory automation.
• LTM Suite LTM (Lifetime Management) Suite is a global M2M application enabling real-time medical device fleet management. It interconnects manufacturers, service professionals, and end users under one application for device monitoring, diagnostics, remote support, predictive maintenance, ticketing, software management, remote sessions, access management, log files, and compliance reporting for regulated markets (FDA, IVDR). Target customers: medical device manufacturers, hospitals, and laboratories.
• SOLAR Suite SOLAR Suite is a lab automation software platform integrating with any IVD instrument and liquid handling platform. It comprises eight modules: PCR Setup, Nucleic Acid Extraction, Sample Preparation, Serial Dilution, Hit-Picking, Normalization, Reformatting, and Assay Reading. OEMs can select module combinations for customized solutions, with LIMS connectivity and barcode-driven workflow support. Target customers: IVD instrument manufacturers and OEMs.
• CLEIS CLEIS is a tailor-made software solution for automatic reading, analysis, and interpretation of CLART-based diagnostic tests. It processes 1 to 96 samples per run, performing detection and analysis of micro spots through colorimetric detection and microarray pattern analysis. Target customers: molecular diagnostics laboratories and OEMs using CLART technology.
• CLEISplus CLEISplus is a software platform controlling a fully automated electromedical device for microarray processing. It provides transparent interaction with liquid handler instruments, imaging devices, and the CLART platform through an intuitive GUI with step-by-step workflow guidance, covering the full process from denatured amplification to diagnostic report issuance. Target customers: molecular diagnostics laboratories and OEMs.
• AUTRAX AUTRAX is software for automated nucleic acid extraction and PCR mastermix preparation. It is integrated with Liferiver Bio-Tech automated workstations and ensures test consistency and reliability through precision pipetting systems with real-time process monitoring and error notification. Target customers: molecular diagnostics OEMs and laboratories.
• OHLink OHLink is a digital platform developed for the PREPARE-TID consortium, providing the digital backbone for transboundary infectious disease surveillance and communication. It supports a comprehensive One Health approach across human, animal, and environmental health domains for pandemic preparedness and rapid response deployment. Target customers: public health authorities, research institutions, and consortium partners.
• Regulatory Affairs Consultation Consultation services on software regulatory affairs helping clients understand, implement, and conform to regulatory requirements including EU MDR, IVDR, FDA 21 CFR Part 820, ISO 13485, IEC 62304, ISO 14971, IEC 62366, IEC 82304, HIPAA, and GDPR. Services cover regulatory strategy, technical documentation, compliance testing, and audit readiness. Target customers: MedTech companies, medical device manufacturers, and IVD developers.
• Quality Assurance (QA) Testing Precision QA testing services for medical software ensuring compliance, security, and user satisfaction. Services include full cycle testing following ISO 13485 and IEC 62304, usability testing per EN IEC 62366, and security testing per HIPAA, GDPR, and FDA cybersecurity guidelines. Target customers: medical software developers and MedTech companies.

Quantifiable outcome

• NU-RISE PRO-DOSE system achieved U.S. FDA 510(k) clearance in November 2025 with Repado's software contribution for data acquisition, signal interpretation, and real-time visualization
• +3 more outcomes

Named customers11 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration5 records

AI capability3 records

Feature6 records

Partnerships

16 partnerships are on record, tiered flagship, core and minor.

• Aces DiagnosticsflagshipStrategic or Co-development Partner · 16 December 2025Repado (alongside Protavio) announced a partnership with Aces Diagnostics to develop the LymeSeek™ diagnostic test for Lyme disease, using multiplexed immunoassay technology and machine-learning algorithms. The collaboration aims to advance toward commercialization including FDA submission, meeting regulatory standards for a clinically accurate diagnostic.
• NU-RISEflagshipStrategic or Co-development Partner · 1 November 2025Repado contributed to NU-RISE's PRO-DOSE system FDA 510(k) clearance (November 2025), developing software for real-time radiotherapy dosimetry data acquisition, signal interpretation, and visualization. Collaboration spanned years of joint R&D, rigorous testing, and alignment across engineering, quality, and regulatory disciplines to meet FDA expectations under enhanced documentation requirements.
• Certest BioteccoreStrategic or Co-development PartnerSWIS™ software powers Certest's VIASURE V-Flex automated liquid handling platform running on Tecan's Cavro Magni-flex. SWIS™ CORE enables Certest's specialists to develop pipetting protocols; SWIS™ BUSINESS provides the end-user GUI for instrument operation. LTM integration enables real-time monitoring of the global installed base for proactive support.
• GENOMICA SAUcoreStrategic or Co-development PartnerRepado is the software partner for GENOMICA's CAR® and AUTOCLART® Plus Solutions using CLART® technology. Repado actively supported GENOMICA worldwide in the COVID-19 fight following CE-IVD approval of their diagnostic kits, which can analyze 96 patient samples in less than 5 hours.
• Liferiver (Shanghai ZJ Bio-Tech Co., Ltd.)coreStrategic or Co-development PartnerRepado developed Autrax software integrated into Liferiver's automated workstation for fully automated nucleic acid extraction and PCR mastermix preparation. The software ensures test consistency and reliability through a precision pipetting system.
• University of GlasgowminorStrategic or Co-development PartnerRepado received an H2020 Marie Sklodowska-Curie Action grant for a strategic partnership under the MSCA Fellowship with the University of Glasgow, supporting research and innovation collaboration.
• SiLA ConsortiumcoreTechnology or IntegrationRepado joined the SiLA Consortium to contribute to the development of free and open system communication and data standards for connecting scientists with laboratory data. Repado brings expertise in life science software, robotics, and automation market needs within a regulated and standardized environment.
• PREPARE-TID Consortium (EU Horizon Europe)flagshipStrategic or Co-development PartnerRepado is part of a multidisciplinary EU Horizon Europe research consortium developing rapid diagnostics for emergency transboundary infectious diseases over 4 years. Repado is responsible for the design and development of the digital backbone (OHLink platform) for TID surveillance and communication supporting a comprehensive One Health approach. Consortium includes biomedical researchers, epidemiologists, clinicians, and veterinarians.
• RocheminorStrategic or Co-development PartnerListed as a selected reference customer and partner in Repado's partner network.
• TecancoreStrategic or Co-development PartnerTecan's Cavro Magni-flex liquid handling platform is integrated with SWIS™ software for Certest's VIASURE V-Flex application. Listed as a selected reference partner and technology platform partner.
• Miltenyi BiotecminorStrategic or Co-development PartnerListed as a selected reference customer and partner in Repado's partner network.
• HAIN LifescienceminorStrategic or Co-development PartnerListed as a selected reference customer and partner in Repado's partner network.
• PharmaMarminorStrategic or Co-development PartnerListed as a selected reference customer and partner in Repado's partner network.
• InterLabServiceminorStrategic or Co-development PartnerListed as a selected reference customer and partner in Repado's partner network.
• Innovation GreeceminorStrategic or Co-development PartnerRepado joined Innovation Greece, an association of innovative companies striving to integrate innovation into everyday practices, products and services.
• SCIENION (BICO company)coreStrategic or Co-development PartnerRepado developed SCIENION's Product Configurator tool using augmented reality to configure and view the sciFLEXARRAYER product line.

Scale indicators6 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• Molecular Devices (Danaher): Danaher-owned lab automation and screening instrument vendor with proprietary software for plate-handling, imaging, and assay analysis. Broad incumbent competing in the same OEM-instrument-software category Repado targets with SWIS.
• Hamilton Company: Established liquid handling and lab automation OEM with proprietary Venus software stack. Competes with Repado in the OEM-instrument-software category where instrument vendors increasingly ship native regulated software.
• Veeva Systems: Dominant regulated life sciences cloud platform spanning clinical, regulatory, and quality. While much larger and broader, Veeva competes for the same regulated pharma/diagnostics software wallet as Repado's regulatory affairs and quality offerings.
• Tietoevry: Nordic-headquartered IT services and software firm with a Life Sciences practice covering regulated software, MDR/IVDR, and clinical applications. Broader incumbent competing for Repado's regulated MedTech custom development work.

Emerging players

• Benchling: Cloud-native R&D platform for biotech and pharma labs (notebook, registry, assay workflows). Emerging competitor in lab informatics for life sciences, addressing overlapping use cases around assay data interpretation and LIMS connectivity.
• Dotmatics: Scientific informatics platform for R&D labs covering ELN, LIMS, and data analysis. Overlaps with Repado's assay data interpretation (SWIS Analyze) and regulated lab informatics positioning.

Direct peers

• STARLIMS (Abbott): Laboratory Information Management System (LIMS) platform serving regulated IVD and clinical labs. Competes with Repado's SWIS and SOLAR products in lab informatics and 21 CFR Part 11 compliant workflow management.
• Zühlke Group: Swiss-headquartered technology and software consultancy with a dedicated MedTech and regulated software practice (ISO 13485, IEC 62304). Closest geographic and capability analog to Repado's certified medical software development services.
• LabVantage Solutions: Enterprise LIMS provider for pharmaceutical, biotech, and diagnostics labs with strong compliance (GxP, FDA Part 11) capabilities. Direct overlap with Repado's lab automation and compliance-ready software positioning.
• Promadis GmbH: Germany-based medical device software services and consultancy specializing in MDR/IVDR compliance and IEC 62304 development. Closest size and capability analog to Repado's regulated medical software services offering in the European market.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/repado-ag

Compliance12 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

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 Repado