What SG Medical does

SG Medical is a privately-held medical device contract manufacturer founded in 2017 and headquartered at the Campus Biotech Innovation Park in Geneva, Switzerland, with manufacturing operations in Tunis, Tunisia (operated through wholly-owned subsidiary SG MedTech). The company specializes in highest-risk Class III medical devices under EU MDR 2017/745, with a focused portfolio built around complex catheter design, development, and manufacturing for electrophysiology, interventional cardiology, and neurovascular applications. Its service offering spans the full product lifecycle, from early-stage design and prototyping through design-for-manufacturing, process development, manufacturing transfer and validation, scalable production in ISO 7/8 cleanrooms, and packaging of sterilized finished devices.

The company's manufacturing technology stack is centered on micro assembly of components ranging from 50μm to 3mm, reflowing and shaft wire embedding (0.75 Fr to 32 Fr), UV/IR gluing from 72μm fibers, laser welding, soldering below 100μm, optical connectorization (LC/APC), and integration of electrical, optical, and thermocouple sensors. Both the Geneva headquarters and the Tunis manufacturing site hold ISO 13485:2016 certification (audited by Bureau Veritas), with the manufacturing facility operating ISO 7 qualified cleanrooms under ISO 14644. The 2023 ISO 13485 scope extension added packaging and marketing/sales activities, broadening the addressable service portfolio.

SG Medical operates a B2B, enterprise field-sales go-to-market targeting medical device OEMs and innovative startups requiring Class III catheter contract manufacturing. Revenue is generated through professional services and contract manufacturing agreements; no pricing is publicly disclosed. The company is founder-led by CEO Slim Gharbi (EPFL bioengineering background, ex-Endosense acquired by St Jude Medical/Abbott) and remains privately held with no institutional funding. Marketing relies on trade show participation (notably MEDICA), a content-led corporate website, and direct enterprise outreach via contact forms. The firm appears to be at an early-commercialization stage, with regulatory and capability infrastructure established but no disclosed revenue, named customers, or external capital.

Name

SG Medical

Legal name

SG Medical

Website

https://sgmedical.com

Company type

Private

Founded year

2017

Operating status

Operating

Headcount range

11–50 employees

Short description

SG Medical is a Swiss-headquartered (Geneva) medical device contract manufacturer specializing in Class III complex catheter design, development, and manufacturing for medical device OEMs and startups in electrophysiology, interventional cardiology, and neurovascular applications, with production in Tunis, Tunisia.

Ownership category

akta.pro rank

Product category

Medical Device Contract Manufacturing

NAICS

Surgical and Medical Instrument Manufacturing (339112)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Quality Management Systems (QMS) & GxP Documentation (HLAGAKAD)

Keywords

• Medical device manufacturing
• Contract catheter manufacturing
• Complex catheter design
• Class III medical devices
• Medical device OEM services

Headquarters

HQ city

Geneva

HQ country

Switzerland

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Operations, Technology or R&D, Infrastructure, Supply Chain

Revenue model

1. Contract Manufacturing Services: SG Medical generates revenue primarily through contract manufacturing services for medical device companies. As an OEM manufacturer, they provide full-service manufacturing from early design stage through prototyping, verification, and full-scale production of complex catheters and medical devices under ISO 13485:2016 certification.
2. Design & Development Services: Complete range of development services including catheter design, prototyping, and product development. Revenue generated from design engineering, verification and validation support, and documentation compliance services.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

SG Medical is a B2B medical device contract manufacturer that designs, develops, prototypes, and mass-produces complex Class III MDR 2017/745 catheters for medical device OEMs. The company operates ISO 7/8 cleanrooms in Tunis, Tunisia, and delivers end-to-end catheter manufacturing services — including design, process development, scalability, manufacturing transfer and validation, and quality/regulatory support — primarily for electrophysiology, interventional cardiology, and neurovascular applications.

Product overview

SG Medical is a medical device contract manufacturer specializing in complex Class III MDR 2017/745 medical devices. The company offers an integrated portfolio spanning design services (Design & Development, Design for Manufacturing, Design Evaluation, Engineering), manufacturing capabilities (Engineering & Process Development, Scalability, Manufacturing Solutions, Manufacturing Transfer & Validation), and quality/regulatory services. Core products include Complex Catheters with mechanical, sensor-integrated, and connectorization capabilities for electrophysiology, interventional cardiology, and neurovascular applications. Both Geneva headquarters and Tunis manufacturing site are ISO 13485:2016 certified.

Differentiator

Problem solved

Functional benefit

Products and services

• Complex Catheters Custom, highly engineered Class III catheters with optional optical or electrical sensors integrated in 6/8 French sizes, including mechanical catheters (steerable, custom shaft design, handle assembly, irrigation), sensor-integrated catheters, and electrical/optical connectorizations for medical device OEMs in electrophysiology, interventional cardiology, and neurovascular applications.
• Engineering & Process Development Process development services for medical device OEMs including UV, IR, and oven gluing, soldering, laser welding, and lamination (reflow) capabilities, delivered by skilled engineers and technicians in ISO 7/8 cleanrooms from early-stage prototypes to commercial products.
• Scalability Manufacturing capabilities that support the transition from development phase to industrialization for medical device OEMs, including pilot manufacturing and volume manufacturing in ISO 7/8 cleanrooms with multi-shift production.
• Manufacturing Solutions Suite of catheter manufacturing technology solutions for medical device OEMs including micro assembly, reflowing, segment fusing, bonding, optical connectorization, soldering, cutting, hydrophilic coating, packaging, QA inspection and testing, and chemical stripping.
• Manufacturing Transfer & Validation OEM manufacturing transfer and validation services for medical device OEMs, covering device transfer at different stages (early stage, R&D prototype, V&V phase, clinical, commercial), including master validation planning, risk analysis, and manufacturing line validation documentation.
• Design & Development Complete catheter design, prototyping, and product development services for medical device OEMs, including requirements specification, CAD/simulation, material selection, process definition, risk analysis, and documentation compliance.
• Design for Manufacturing Design for manufacturing guidance for medical device OEMs, including early involvement in design prototyping, manufacturing scale-up integration, yield target integration, and cost-savings projects.
• Design Evaluation Verification and validation services for medical device OEMs, including materials testing, design/process verification, metrology analysis, bench tests, accelerated aging tests, and packaging tests compliant with ISO 10555.
• Engineering Custom engineering services for medical device OEMs including redesign of customer products, development process improvement, project planning, design of experiments, and process validation.
• Quality Services Quality engineering and process validation services for medical device OEMs, including design development planning, risk analysis, process capability studies, IQ/OQ/PQ/PPQ validations, and quality inspection from incoming controls to final inspection.

Segments2 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature8 records

Partnerships

Three partnerships are on record, tiered minor and core.

• ER2I GroupminorOthersER2I Group is a supplier partner that performed the ISO 7 cleanroom qualification for SG Medical's manufacturing facilities. They assisted with cleanroom requalification activities in compliance with GMP and ISO 14644 standards.
• Bureau VeritascoreOthersBureau Veritas serves as the independent certification body that conducts annual audits of SG Medical's quality management system. They verify conformity with international standards, ISO norms, and regulatory requirements to help clients bring safer products to market.
• Elyos DigitalminorOthersElyos Digital is a Tunisia-based web development company that created SG Medical's website. Located in Monastir, Tunisia.

Scale indicators5 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• Flex Ltd: Flex's Health Solutions business provides medical device design and contract manufacturing at scale for global OEMs — broader portfolio but overlapping catheter and complex device capabilities.
• Jabil Healthcare: Jabil Healthcare is the medical device arm of a global EMS giant, offering large-scale catheter and Class III manufacturing for major OEMs — comparable services but at much broader scale and portfolio breadth.
• Plexus Corp: Plexus is a global EMS/CDMO serving regulated medical device OEMs with design, manufacturing, and aftermarket services — comparable customer base but less catheter-specialized.
• Sanmina Corporation: Sanmina operates a Medical division providing complex Class III device design, manufacturing, and supply chain services for OEMs — comparable regulatory and catheter-adjacent capabilities.
• Benchmark Electronics: Benchmark (post-Plexus acquisition) provides EMS and medical device manufacturing services for OEMs, including precision catheter-adjacent assembly — comparable contract manufacturer profile at larger scale.

Direct peers

• Viant Medical: Viant Medical is a pure-play medical device contract manufacturer offering design, engineering, and full-scale production for OEMs — directly comparable end-to-end CDMO model for Class II/III devices.
• Integer Holdings: Integer Holdings is a leading medical device outsource manufacturer with dedicated catheter and complex device capabilities serving cardiovascular and other OEMs — closely comparable target customers and Class III competency profile.
• Cirtec Medical: Cirtec Medical is a contract manufacturer focused on minimally invasive and active catheter devices for neurovascular, cardiovascular, and structural heart OEMs — directly comparable complex catheter CDMO niche.
• Nordson Medical: Nordson's Medical division designs and manufactures precision catheter components and finished devices for OEMs — closely comparable catheter focus and complex device engineering services.
• Creganna Medical (TE Connectivity): Creganna Medical (now part of TE Connectivity) pioneered the catheter contract manufacturing model serving EP and interventional cardiology OEMs — historically the closest precedent for SG Medical's specialized catheter CDMO model.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/sg-medical

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

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 SG Medical