Cisteo Medical

What Cisteo Medical does

Cisteo Medical is a French Contract Development and Manufacturing Organization (CDMO) headquartered in Besançon that designs, develops, certifies, and manufactures medical devices on behalf of medtech start-ups, spin-offs, and established manufacturers. Founded in 2010 by Christophe Moureaux, the firm operates across the full device lifecycle — feasibility, prototype, First In Human, clinical and preclinical work, industrialization, cleanroom production, and CE marking / FDA clearance support — with a particular emphasis on complex Class III devices, active implantable medical devices (AIMD), surgical instrumentation, and electro-medical devices integrating embedded software.

Technically, Cisteo leverages microtechnology expertise rooted in the Besançon watchmaking cluster, combining mechatronics, micromechanics, electronics, and IEC 62304-compliant software design. Production runs in ISO5 and ISO7 cleanrooms totalling ~250 m² within a 1,300 m² dedicated facility that also houses two R&D laboratories (micromechanics, electronics), a prototyping workshop, and an assembly/wiring workshop; a second nearby manufacturing site is now ISO 13485-certified. Differentiated process capabilities include nitinol shaping and heat treatment, 5-axis laser welding, silicone overmolding, optical-fiber-based miniaturization, multilayer PCB design (flexible, rigid, hybrid), wireless/battery management, and Class A/B/C software development per IEC 62304 and EN 60601-1.

Commercially, Cisteo monetises through project-based contract R&D, contract manufacturing, regulatory and quality management system consulting (Cisteo CONSULTING, DM Hotline), and Qualiopi-certified training. Approximately 90% of revenue derives from medtech start-ups and spin-offs. The firm serves clients across France, Switzerland, Belgium, the Netherlands, the USA, Israel, and Norway, and in November 2025 joined the Agôn Electronics group as a member company while opening a Belgian subsidiary in the Charleroi Biopark in 2024–2025.

Name

Cisteo Medical

Legal name

Cisteo MEDICAL

Website

https://cisteomedical.com

Company type

Private

Founded year

2010

Operating status

Operating

Headcount range

11–50 employees

Short description

Cisteo Medical is a French CDMO that designs, certifies, and manufactures Class III medical devices, active implantable medical devices (AIMD), and electro-medical devices for medtech start-ups and manufacturers, with operations in France and Belgium.

Ownership category

akta.pro rank

Product category

Medical Device Contract Development and Manufacturing

NAICS

Surgical and Medical Instrument Manufacturing (339112), Surgical Appliance and Supplies Manufacturing (339113), Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Medical Equipment and Supplies Manufacturing (3391)

SIC

Surgical & Medical Instruments & Apparatus (3841), Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842), Electromedical & Electrotherapeutic Apparatus (3845)

akta.pro primary industry

Sterile Fill-Finish & Aseptic Manufacturing CDMO (HLAGABAH)

akta.pro secondary industries

Clinical Trial Material (CTM) Manufacturing & Supply CDMO (HLAGABAK), Packaging, Labeling & Serialization (Clinical/Commercial) CDMO (HLAGABAJ)

Keywords

• Medical device development
• Contract medical manufacturing
• Regulatory compliance services
• Active implantable devices
• Medical device certification

Headquarters

HQ city

Besançon

HQ country

France

HQ region

Europe

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Contract R&D Services: Research and development services for medical devices from concept to prototype, including mechatronic, microtechnical, electronic and software solutions
2. Contract Manufacturing: Manufacturing and assembly of medical devices in controlled environments (ISO5/ISO7 cleanrooms), including silicone transformation, nitinol shaping, laser welding, and packaging
3. Regulatory Support: CE marking and FDA clearance support, quality management system implementation (ISO 13485), and technical file drafting
4. Training Services: Qualiopi-certified training courses on medical devices including risk management, usability, biocompatibility, clinical evaluation

Pricing tiers

Go-to-market motion2 records

Distribution channels1 record

Marketing channels6 records

Core offering

Cisteo Medical is a Contract Development and Manufacturing Organization (CDMO) for medical devices, providing end-to-end services from R&D through industrialization to production. The company specializes in mechatronic, microtechnical, electronic, and embedded software solutions for class I-III medical devices, including active implantable medical devices (AIMD), surgical instrumentation, and electro-medical devices, with manufacturing performed in ISO5 and ISO7 cleanrooms.

Product overview

Cisteo Medical is a Contract Development and Manufacturing Organization (CDMO) for medical devices operating as a single unified service provider. The core offerings include Research and Development Services (R&D for mechatronic, microtechnical, electronic and software solutions up to class III), Manufacturing and Assembly Services (production in ISO5/ISO7 cleanrooms), CE Marking Support, ISO 13485 Quality Management System Support, Medical Device Training (Qualiopi-certified), and DM Hotline. Additional specialized services include Cisteo CONSULTING for regulatory affairs, Active Implantable Medical Device (AIMD) Services, Electro-Medical Device Services with embedded software development, and Electronic/Software Development. The company also operates Cisteo MEDICAL Belgium as a subsidiary. Services span from initial concept through industrialization to mass production, with a focus on supporting medtech start-ups (90% of business).

Differentiator

Problem solved

Functional benefit

Brands

• Cisteo CONSULTING: Regulatory and standards consulting activity launched in September 2020 to help medical device manufacturers with CE marking and ISO 13485 quality management system certification.

Products and services

• Research and Development (R&D) Services Contract R&D services for medical devices up to class III and active implants, including feasibility studies, POC, prototype, First In Human, and clinical/preclinical trials, covering mechatronic, microtechnical, electronic, and software solutions.
• Manufacturing and Assembly Services Customized industrialization and production of medical devices in Controlled Atmosphere Zone (CAZ) with ISO5 and ISO7 cleanrooms, including silicone transformation, nitinol shaping, 5-axis laser welding, laser marking, heat treatment, cleaning, and packaging.
• CE Marking Support Regulatory support in drafting technical files for CE marking or FDA submission, including biocompatibility demonstration and regulatory validations per CE/FDA and ISO 13485/21 CFR part 820 standards.
• ISO 13485 Quality Management System Support Support in setting up and implementing a quality management system (QMS) in accordance with ISO 13485 and/or 21 CFR part 820 standards for medical device manufacturers.
• Medical Device Training Qualiopi-certified training courses on medical devices covering CE marking, certification, QMS, risk management, usability, biocompatibility, and clinical evaluation for healthcare professionals and manufacturers.
• DM Hotline (Hotline DM) Regulatory and quality hotline service for medical device questions, providing expert answers on regulatory and quality matters, managed by the Quality and Regulatory Affairs Manager.
• Cisteo CONSULTING Regulatory and standards consulting sub-brand launched in September 2020 to support medical device manufacturers with their approval process and ISO 13485 quality system management.

Quantifiable outcome

• Revenue growth from €145,000 to €1,650,000 over 10 years (11x increase)
• +2 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature8 records

Partnerships

Six partnerships are on record, tiered core and minor.

• Agôn ElectronicscoreStrategic or Co-development PartnerCisteo Medical joined Agôn Electronics group, a leading French player in the design and manufacture of high-value electronic products. This partnership strengthens Cisteo's capabilities in electronic manufacturing.
• Synergia MedicalcoreStrategic or Co-development PartnerBelgian optoelectronics pioneer for whom Cisteo is industrializing and putting into production their neurostimulation device. Represents a key Franco-Belgian collaboration in active implantable medical devices.
• SambrinvestminorStrategic or Co-development PartnerBelgian investment organization that actively supported the opening of Cisteo Medical Belgium subsidiary in Charleroi.
• SPW-EER (Walloon Public Service - Economy, Employment and Research)minorStrategic or Co-development PartnerWalloon government authority that actively supported the opening of Cisteo Medical Belgium subsidiary to strengthen the Belgian medtech ecosystem.
• Brussels South Charleroi BioparkcoreStrategic or Co-development PartnerInternationally renowned biotech-focused biopark in Charleroi where Cisteo Medical Belgium is located. Biopark aims to develop medtech sector and sees Cisteo's arrival as strengthening the Belgian medtech ecosystem.
• Thread & LiftcoreStrategic or Co-development PartnerBelgian manufacturer of permanent tensor threads for cosmetic surgery. Cisteo completed entire development phase, industrialization, and CE marking (class IIb), now manufacturing tens of thousands of wires. Represents complete CDMO partnership.

Scale indicators8 records

Recent moves10 records

Expansion highlights6 records

Direct peers

• Starfish Medical: Canadian medical device design, development, and contract manufacturing organization providing end-to-end services from concept through production for Class II/III devices. Directly comparable to Cisteo as a specialized medtech CDMO serving start-ups and OEMs.
• Donatelle: US-based medical device contract manufacturer specializing in complex implantable and interventional devices with cleanroom capabilities. Comparable to Cisteo's Class III AIMD and surgical instrumentation focus.
• Tegra Medical: Medical device contract manufacturer focused on complex implants, instruments, and minimally invasive delivery systems with nitinol processing expertise. Comparable to Cisteo's nitinol shaping, laser welding, and AIMD cleanroom manufacturing offering.
• Viant Medical: Global end-to-end medical device contract manufacturer and OEM with capabilities in design, engineering, component manufacturing, and finished device assembly. Comparable to Cisteo as a one-stop medtech CDMO for start-ups and OEMs.
• Medical Murray: US medical device contract manufacturer and product development firm offering design, prototyping, and production services for Class II/III implants and devices. Comparable to Cisteo's integrated R&D-to-manufacturing CDMO model for start-ups.
• Confluent Medical Technologies: Specialty medical device manufacturer centered on nitinol components, laser processing, and active implant textiles. Comparable to Cisteo's nitinol processing, laser welding, and Class III active implant manufacturing capabilities.
• Flexan: Medical device contract manufacturer with silicone molding, assembly, and finished device capabilities, particularly for catheters and minimally invasive devices. Comparable to Cisteo's silicone transformation and cleanroom assembly services.
• J-Pac Medical: Medical device contract manufacturer and packager serving start-ups through OEMs with cleanroom assembly, packaging, and serialization services. Comparable to Cisteo's full-service CDMO model emphasizing cleanroom manufacturing and regulatory support for medtech clients.

Broad incumbents

• Integer Holdings: Large medical device outsource manufacturer offering services across cardio, vascular, neuromodulation, and advanced surgical portfolios. Comparable to Cisteo across multiple AIMD and surgical segments but at significantly greater scale and breadth.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks5 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/@cisteomedical
• LinkedInfr.linkedin.com/company/cisteo-medical

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Subsidiaries1 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 Cisteo Medical