MedFact
MedFact engineering GmbH is a German specialty medical device CDMO designing, developing, and manufacturing catheters, tubing sets, and RF generator accessories for electrophysiology, cardiology, and adjacent verticals on an OEM/ODM basis for multinational device companies and start-ups.
- Company typePrivate
- Founded2008
- HeadquartersLörrach, Germany
- Headcount1–10
- GTM typeB2B
- OfferingHardware or Manufacturing
What MedFact does
MedFact engineering GmbH is a privately held, founder-owned specialty medical device contract design, development, and manufacturing organization (CDMO) headquartered in Lörrach, Germany, on the Swiss border near Basel. Founded in October 2008 by Jörg Reinhardt — a biomedical engineer with 30+ years of EP and cardiology experience from his prior tenure as CEO of VascoMed — the company operates from a facility that includes a Class 10,000 cleanroom (US Federal Standard 209b) plus ISO 7 and ISO 8 cleanrooms for cleaning, packaging, and sterilization. MedFact has been EN ISO 13485 certified since 2009 and FDA-listed since 2015, with a scope that has progressively expanded to cover cardiovascular/endovascular, electrophysiology, neurology, infusion therapy, gastroenterology, gynaecology, and neonatology applications.
The company's product portfolio centers on catheters and tubing sets, including therapeutic catheters (EasyControl, EasyCool, EasyFlush families), magnetic navigation catheters (MagnoBlate, MagnoFlush), and diagnostic catheters (EasyLoop, EasyMap MAP, MagnoLoop, MagnoMap MAP), complemented by a broad adapter cable and tubing set accessory line (MagnoConnect, BSC Connect, EasyConnect) that ensures interoperability with all major RF ablation generator platforms from Abbott, Biosense Webster, Boston Scientific, Stockert, and Osypka. With 28 employees, including 6 dedicated to R&D and regulatory affairs, MedFact serves both large multinational medical device companies and creative start-ups on a quote-based, project-driven basis. Revenue is generated through a mix of OEM hardware sales, design and development services, OEM contract manufacturing, cleaning/packaging/sterilization services, and quality management/regulatory affairs consulting — with MedFact explicitly disclaiming any interest in the IP, copyrights, or royalties of OEM products, positioning itself as a pure white-label manufacturing and engineering partner.
MedFact firmographics
Firmographics- Name
- MedFact
- Legal name
- MedFact engineering GmbH
- Website
- https://medfact.eu
- Company type
- Private
- Founded year
- 2008
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- MedFact engineering GmbH is a German specialty medical device CDMO designing, developing, and manufacturing catheters, tubing sets, and RF generator accessories for electrophysiology, cardiology, and adjacent verticals on an OEM/ODM basis for multinational device companies and start-ups.
- Ownership category
- akta.pro rank
MedFact industry classification
Industry- Product category
- Medical Device Contract Manufacturing
- NAICS
- Surgical and Medical Instrument Manufacturing (339112), Surgical Appliance and Supplies Manufacturing (339113), Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)
- SIC
- Surgical & Medical Instruments & Apparatus (3841)
- akta.pro primary industry
- Vascular Access Devices (AV Grafts, Catheters, Fistula Accessories) (HLAHAKAE)
- akta.pro secondary industries
- Medical & Life Sciences Injection Molding (Devices, Diagnostics, Cleanroom) (IMANAFAC), Sterilization Services & Contract Reprocessing (ETO/Gamma/E-beam providers) (HLAHANAB), Diagnostic & Laboratory Packaging (Specimen Containers, Transport Tubes) (IMALAIAF)
Keywords
Where MedFact is headquartered
LocationHeadquarters
- HQ city
- Lörrach
- HQ country
- Germany
- HQ region
- Europe
Offices1 record
Markets served
MedFact business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Personnel, Infrastructure, Operations, Technology or R&D, Supply Chain, Marketing or Sales
Revenue model
- Medical Device Manufacturing (OEM/ODM): Design, development and manufacture of medical devices for other companies (OEM production), including catheters and tubing sets for cardiovascular/endovascular applications, electrophysiology, neurology, infusion therapy, gastroenterology, gynaecology and neonatology
- Design and Development Services: Full service solution from idea to product including design validation to ensure all requirements are fulfilled
- Cleaning, Packaging and Sterilization Services: Cleaning and packaging services in ISO 7 and ISO 8 cleanrooms, with sterilization arranged as needed
- Quality Management and Regulatory Consulting: Services relating to quality management and approval of medical devices with notified bodies, including regulatory advice and study planning
- Accessories and Cables: Sale of cables, adapters, and tubing sets including BSC Connect Adapter Cables, MagnoConnect cables, EasyConnect adapters, and irrigation tubing sets
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Custom quotation for products and services |
Go-to-market motion1 record
Distribution channels1 record
Marketing channels4 records
MedFact product offering
Product offeringCore offering
MedFact engineering GmbH designs, develops, and manufactures medical devices—primarily catheters (mapping, ablation, and diagnostic) and tubing sets—for other medical device companies on an OEM/ODM basis. The company also supplies compatible connection cables, adapters, and irrigation tubing sets for major RF ablation generator systems, and offers end-to-end services including design validation, contract manufacturing, cleaning/packaging in ISO 7 and ISO 8 cleanrooms, sterilization coordination, and quality management and regulatory affairs consulting for cardiovascular, electrophysiology, neurology, infusion therapy, gastroenterology, gynaecology, and neonatology applications.
Product overview
MedFact Engineering GmbH offers a comprehensive portfolio of medical devices and contract manufacturing services. The core product lines include therapeutic catheters (EasyControl, EasyControl S, EasyCool, EasyCool S, EasyFlush, EasyFlush S), therapeutic-magnetic navigational catheters (MagnoBlate, MagnoFlush), and diagnostic catheters (EasyLoop, EasyMap MAP, MagnoLoop, MagnoMap MAP). These catheter products are complemented by a full range of accessories including cables and adapters that ensure compatibility with major RF ablation generator systems from Abbott, Biosense Webster, Boston Scientific, Stockert, and Osypka, as well as tubing sets for irrigation pumps. MedFact also provides end-to-end services including design and development, OEM production, cleaning/packaging/sterilization in ISO 7/8 cleanrooms, and quality management/regulatory affairs consulting. The company specializes in catheters and tubing sets for electrophysiology, cardiology, neurology, infusion therapy, gastroenterology, gynaecology, and neonatology.
Differentiator
Problem solved
Functional benefit
Brands
- EasyControl: Manual deflectable Mapping- and Ablation-Catheter product line available with gold (G) or Pt-Ir (P) electrodes
- EasyCool
- EasyFlush
- MagnoBlate
- MagnoFlush
- EasyLoop
- EasyMap MAP
- MagnoLoop
- MagnoMap MAP
- BSC Connect Adapter Cable
- MagnoConnect Cable
- EasyConnect Cable
- EasyCool CF
- Irrigation Tubing Set MQ
Products and services
- EasyControl / EasyControl S Manual Deflectable Mapping and Ablation Catheters Manual deflectable mapping and ablation catheters used for therapeutic electrophysiology procedures. Available with gold or Pt-Ir electrodes, in multiple sizes and as a stiff (S) variant, sold to medical device companies for OEM distribution.
- EasyCool / EasyCool S Irrigated Mapping and Ablation Catheters Irrigated manual deflectable mapping and ablation catheters designed for cooled RF ablation procedures. Available in different sizes and a stiff (S) variant for OEM customers.
- EasyFlush / EasyFlush S Irrigated Ablation Catheters Manual deflectable ablation catheters with flush irrigation capability for therapeutic electrophysiology use, offered in multiple sizes and a stiff (S) variant.
- MagnoBlate Magnetic Remote Mapping and Ablation Catheter Magnetic remote navigation mapping and ablation catheter for therapeutic EP procedures. Available with gold or Pt-Ir electrodes and in different sizes.
- MagnoFlush Irrigated Magnetic Navigation Mapping and Ablation Catheter Irrigated magnetic navigation mapping and ablation catheter offered with gold or Pt-Ir electrodes for cooled magnetic-navigation ablation procedures.
- EasyLoop PV Mapping Catheter Manual deflectable spiral-formed pulmonary vein (PV) mapping catheter for diagnostic EP procedures. Available in different loop diameters, deflectable tip lengths, and electrode materials.
- EasyMap MAP Catheter Diagnostic catheter for Recording Monophasic Action-Potentials (MAP) and for Intracardial Pacing, available in different lengths of the deflectable tip.
- MagnoLoop Magnetic Remote PV Mapping and Pacing Catheter Magnetic remote spiral-formed PV mapping and pacing catheter. Available in different loop diameters and electrode materials.
- MagnoMap MAP Magnetic Remote Catheter Magnetic remote catheter for Recording Monophasic Action-Potentials (MAP) and Intracardial Pacing (Reference 100-057). Only available in one size.
- MagnoConnect Connection Cable Series Connection cables linking MedFact mapping and ablation catheters to a range of major RF ablation generators (Abbott IBI-1500T11, Osypka HAT 300/HAT 500, Biosense Webster EP SHUTTLE/Smart Ablate, ATAKR, Stockert Smart Ablate, Maestro 4000). Models include MagnoConnect I, H, H500, E, A, SmA, and M.
- BSC Connect Adapter Cable Series Adapter cables connecting Boston Scientific catheters (Irrigated-Blazer, Thermistor, IntellaTip MIFI, ThermoCool, Blazer) to Abbott IBI-Ampere, Biosense Webster Smart Ablate, Stockert Smart Ablate, and Maestro 4000 RF ablation generators. Reference numbers 100-339, 100-414, 100-507, 100-517, 100-518.
- EasyConnect MAP Cable and Pin/Screw Adapters EasyConnect MAP Cable (4-polar, Reference 104-139) connecting MedFact MAP-Catheters to EP-Recording Systems, plus 2mm Pin-Adapter family (EasyConnect Pin, Screw, Pin 10, Screw 10; References 104-043 to 104-046) for connecting shrouded pins per E-DIN 42802-2.
- Irrigation Tubing Sets for RF Ablation Pumps Tubing sets for irrigated RF ablation catheters compatible with Boston Scientific CoolFlow and MetriQ pumps, SmartAblate pump, and Osypka HAT 500 roll pumps. Includes EasyCool CF (103-050/103-506), Irrigation Tubing Set MQ (103-512), Irrigation Tubing Set SmA (103-523), and Tubing Set H500/Livecool (103-556).
- Design and Development Services for Medical Devices Full-service medical device development solution covering product idea through design, development, validation, and manufacture, including design validation to ensure all requirements are fulfilled. Offered to medical device companies and start-ups.
- OEM Production (Contract Manufacturing) Contract manufacturing of medical devices including all required validations and sterilization. Performed in ISO 7/ISO 8 and Class 10,000 cleanroom environments under EN ISO 13485:2016 quality system.
- Cleaning, Packaging and Labelling Services Cleaning and packaging of medical devices per customer processes in ISO 7 and ISO 8 cleanrooms, with sterilization services arranged as needed.
- Quality Management and Regulatory Affairs Consulting Quality management and assurance services for medical devices, including support for approval with notified bodies, regulatory advice, and clinical study planning and implementation.
Quantifiable outcome
- Successfully transferred to EN ISO 13485:2016 and expanded scope multiple times (2022, 2025)
- +1 more outcomes
Companies that use MedFact
Customer profileNamed customers2 records
Segments7 records
Ideal customer profiles2 records
MedFact technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration16 records
Feature8 records
MedFact partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- VR CoasterminorDuring the Corona crisis in 2020, MedFact partnered with VR Coaster to build eye protection shields using the head mount of VR glasses. MedFact manufactured the shields while VR Coaster provided the headset frames. Featured on Sat.1 breakfast television.
Scale indicators8 records
Recent moves6 records
Expansion highlights4 records
MedFact competitors and assessment
Company assessmentEmerging players
- CardioFocus: Developer of catheter-based laser ablation systems for atrial fibrillation; operates in MedFact's EP catheter space and is a likely OEM-adjacent partner given MedFact's laser-ablation catheter expertise.
- CathRx: Specialized EP catheter company focused on steerable diagnostic and ablation catheters; comparable in scale and product mix to MedFact's therapeutic catheter portfolio.
Broad incumbents
- Integer Holdings: Large medical-device contract development and manufacturing organization with broad catheter capabilities; competes against MedFact for OEM catheter manufacturing work.
- BIOTRONIK: Major German-founded cardiovascular and EP device manufacturer; operates its own EP and catheter programs that consume, and could compete with, MedFact's specialty catheter output.
- Boston Scientific (Electrophysiology): Operates one of the world's largest EP catheter franchises (IntellaTip MIFI, ThermoCool, CoolFlow, Blazer); serves both as MedFact integration partner and in-house manufacturing competitor.
- Jabil Healthcare: Global manufacturing services provider with a healthcare division producing Class III electrophysiology and interventional devices for OEMs; broad incumbent in MedFact's contract-manufacturing niche.
- Biosense Webster (Johnson & Johnson MedTech): Global leader in EP mapping and ablation catheters and generators (CARTO, EP SHUTTLE, Smart Ablate); key integration partner and the largest potential in-house competitor for MedFact's OEM catheter business.
- Abbott (Cardiac Arrhythmias & Heart Failure): Large EP franchise (former St. Jude) making mapping/ablation catheters and RF generators (IBI-1500T11, Maestro 4000); major customer and potential vertical-integration threat to MedFact.
Direct peers
- Oscor: US-based specialized manufacturer of electrophysiology and pacing catheters and accessories; competes for the same OEM and tender-driven EP catheter programs as MedFact.
- VascoMed - Institute for Catheter Technology: German catheter technology specialist founded by MedFact CEO Jörg Reinhardt; closest precedent and most comparable direct peer in EP catheter design and OEM manufacturing.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
MedFact social profiles
Digital presenceMedFact compliance and trust
Trust signalCompliance1 record
MedFact financial estimates
Financial estimateRevenue estimate
Valuation estimate
MedFact leadership team
Management profileNumber of profiles
Profiles3 records
MedFact funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
MedFact M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about MedFact
What does MedFact do?
MedFact engineering GmbH designs, develops, and manufactures medical devices—primarily catheters (mapping, ablation, and diagnostic) and tubing sets—for other medical device companies on an OEM/ODM basis. The company also supplies compatible connection cables, adapters, and irrigation tubing sets for major RF ablation generator systems, and offers end-to-end services including design validation, contract manufacturing, cleaning/packaging in ISO 7 and ISO 8 cleanrooms, sterilization coordination, and quality management and regulatory affairs consulting for cardiovascular, electrophysiology, neurology, infusion therapy, gastroenterology, gynaecology, and neonatology applications.
Is MedFact a public or private company?
MedFact is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was MedFact founded?
MedFact was founded in 2008. It employs 1 to 10 people.
Where is MedFact based?
MedFact is headquartered in Lörrach, Germany, in the Europe region.
How does MedFact make money?
Five revenue lines are on record. Medical Device Manufacturing (OEM/ODM) is the primary driver. The others are design and Development Services, cleaning, Packaging and Sterilization Services, quality Management and Regulatory Consulting and accessories and Cables.
Who are MedFact's main competitors?
Emerging players on record are CardioFocus and CathRx. Broad incumbents are Integer Holdings, BIOTRONIK, Boston Scientific (Electrophysiology), Jabil Healthcare, Biosense Webster (Johnson & Johnson MedTech) and Abbott (Cardiac Arrhythmias & Heart Failure). Direct peers are Oscor and VascoMed - Institute for Catheter Technology.
Does MedFact have an API?
No public API is recorded for MedFact.
What industry is MedFact in?
MedFact's product category is Medical Device Contract Manufacturing. Its primary akta.pro industry code is HLAHAKAE, Vascular Access Devices (AV Grafts, Catheters, Fistula Accessories), with a secondary code of IMANAFAC, Medical & Life Sciences Injection Molding (Devices, Diagnostics, Cleanroom). Its NAICS code is 339112 and its SIC code is 3841.