Development, prototyping, testing and process validation for catheters, stent and delivery systems
Feinzer GmbH (Catheter Solutions)
Munich · Augsburg · TallinnNew on Amplifa
About Catheter Solutions
Catheter Solutions (Feinzer GmbH) is a Germany-based R&D and consulting company for minimally invasive medical devices. The team supports internationally active medical technology manufacturers in the design, development and commercialization of catheters, access sheaths, balloon catheters, valve delivery systems and stent delivery systems. Services include R&D consulting, product design, prototyping of full devices or sub-assemblies, device testing including CE documentation, setup of pilot lines as well as process validation according to IQ/OQ/PQ and CQV. For manufacturing and prototype creation, processes such as laser welding, laser cutting, braiding, coiling, reflow/lamination, tip forming, balloon blowing, tube cutting, surface treatment, cleaning, sterilization and UV glueing are available. In addition, the company handles complete technology transfer worldwide – from supplier selection to series production handover. Locations are in Munich and Augsburg (Germany) as well as Tallinn (Estonia).
- Site
- Munich
- Processes
- Product Design (development, drawings, BOM), Prototyping (full device or sub-assembly), Laser welding, Laser cutting, Lap joints, Butt welding, Braiding, Coiling
- Materials
- PTFE (Liner), Thermoplastics (thermoplastic materials, catheter/balloon processing), Polyamide (Nylon), Polyether block amide (PEBA), Polyurethane, Polyethylene terephthalate (PET), Polyimide, Silicone rubber
- Certificates
- ISO 13485 (Partner certification), ISO 13485 (Partner)
- Industries
- Medical Technology, Minimally Invasive Medical Devices (Catheters, Stents, Interventional Devices), Minimally Invasive Medical Devices (Catheters, Stents, Interventional Devices)
- 01
R&D Consulting / Product Design
- 02
Prototyping (full device or sub-assembly)
- 03
Device Testing and CE documentation
- 04
Pilot Lines Setup
- 05
Process Validation (IQ/OQ/PQ, CQV)
- 06
Product Line Transfer / Commercialization
Locations
Munich
DEGerman Office
Augsburg
DECompany Headquarters (Feinzer GmbH)
Tallinn
EEMain Office (Hoyf Advisory ÖU)
Product Areas
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Product Design (development, drawings, BOM)Engineering | – | – | – | – | – |
| Prototyping (full device or sub-assembly)Engineering | – | – | – | – | – |
| Laser weldingJoining | – | – | – | – | – |
| Laser cuttingJoining | – | – | – | – | Stainless steel |
| Lap jointsJoining | – | – | – | – | – |
| Butt weldingJoining | – | – | – | – | – |
| BraidingForming | – | – | – | – | – |
| CoilingForming | – | – | – | – | – |
| Reflow / LaminationJoining | – | – | – | – | – |
| Tip forming and weldingJoining | – | – | – | – | – |
| Balloon blowing and formingForming | – | – | – | – | – |
| Tube cuttingMachining | – | – | – | – | – |
| Surface treatmentSurface | – | – | – | – | – |
| Product cleaningSurface | – | – | – | – | – |
| SterilizationSurface | – | – | – | – | – |
| UV glueingJoining | – | – | – | – | – |
| Device Testing according to ISO (CE documentation)Testing | – | – | – | – | – |
| Hydraulic Burst Leak TestingTesting | – | – | – | – | – |
| Radial Force & Hoop Force TestingTesting | – | 220 mm × 60 mm (diameter) | – | – | – |
| Stent Securement TestingTesting | – | – | – | – | – |
| Catheter Testing Services (Fatigue, Flow, Track force, Torque, Push efficiency, Tip stiffness)Testing | – | – | – | – | – |
| Pilot Lines Setup / Product line transferEngineering | – | – | – | – | – |
| Process Validation (IQ/OQ/PQ, CQV, Software Validation)Testing | – | – | – | – | – |
| R&D Consulting / Engineering consultingEngineering | – | – | – | – | – |
2 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| 6-up Liner Stretcher with Tension Control | – | – | – | – | – |
| Catheter Curving Machine (shaping for braided catheters) | – | – | Compatible with any shaped and thermoplastic materials | – | – |
Additional services
Quality and Validation
Device testing is performed including the associated documentation for CE certification; hydraulic burst leak testing up to 5000 psi as well as radial and hoop force testing for products up to 220 mm length and 60 mm diameter are offered. The manufacturing partner is certified according to ISO 13485 (2017).
| Evidence | Munich | Augsburg | Tallinn |
|---|---|---|---|
| ISO 13485 (Partner) |