Development services, test rig construction, metrology and process technology as well as prototype and jig/fixture engineering for medical technology
evos GmbH
Merzbrück 212, 52146 WürselenNew on Amplifa
Development services at eye level
evos GmbH, based in Würselen near Aachen, is a development and engineering service provider with a focus on medical technology. The company offers development services ranging from requirements elaboration and the design and layout of mechanical, electrical and hydraulic systems through to prototypes and pre-series production. Core competencies include the construction of customer-specific test rigs including test method development, CE certification and qualification (DQ/IQ/OQ/PQ), as well as metrology and process technology for optimizing manufacturing and assembly processes. Functional prototypes, hand samples, jigs and fixtures, and production systems are created in the in-house workshop and laboratories – including a hydraulics laboratory with CFD simulation, a laboratory dip-coating system and SLA 3D printing. Examples include blood pump development, cannula development for EKZ (cardiopulmonary bypass) and ECMO, catheter test rigs according to DIN EN ISO 10555-1, and a prototype for monitoring bone healing.
- Site
- Würselen
- Processes
- Development services (requirements management, design and engineering,, Blood pump development (optimization of existing products or new development, CFD simulations), Cannula development for EKZ and ECMO (hydraulic design/characterization), Test rig construction (test method development, conception, assembly, CE certification,, Sustained pressure test rig for catheter testing (1–7 lumens), High-pressure test rig for catheter testing according to DIN EN ISO 10555-1 (burst testing and flow, Test rig for in-process inspection (laser-based metrology), Metrology and process technology (development of manual and (semi-)automated processes,
- Materials
- Nitinol, Plastic, Biocompatible materials, CFD simulation, SLA 3D printing, Dip coating
- Certificates
- Development and documentation modeled on ISO 13485 and the MDR, CE certification of test rigs, Qualification DQ/IQ/OQ/PQ, Catheter testing according to DIN EN ISO 10555-1
- Industries
- Medical technology
- 01
Requirements management
- 02
Feasibility study
- 03
Design and engineering (incl. CFD simulation)
- 04
Prototype and jig/fixture construction
- 05
Metrology and process technology
- 06
Qualification (DQ/IQ/OQ/PQ)
- 07
Production transfer
Materials and processes
Nitinol
Used, among other things, for testing the strength of adhesive bonds when Nitinol is embedded in an adhesive.
Biocompatible materials
Used for blood tests on blood pump prototypes in SLA 3D printing.
Plastic
Used in dip coating and for plastic components of prototypes and jigs/fixtures.
CFD simulation
Theoretical analysis of flows in blood pump and cannula development.
SLA 3D printing
Production of prototypes, optionally from inexpensive or biocompatible materials.
Dip coating
Laboratory system for depositing a plastic from solvent with adjustable dipping speed, immersion angle, drying time and rotation.
Locations
Würselen
DEHeadquarters with laboratories and workshop
- Lot size
- Prototypes, pre-series (1–20 units)
- Materials
- Nitinol, biocompatible materials, plastic
- Hydraulics laboratory
- Dip-coating laboratory system (1 linear axis, 2 rotary axes)
- Sustained pressure test rig (1–7 lumens)
- High-pressure test rig (35 bar, DIN EN ISO 10555-1)
- Test rig for in-process inspection (laser-based metrology)
- SLA 3D printing
Components and examples
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Development services (requirements management, design and engineering,Engineering | – | – | – | – | – |
| Blood pump development (optimization of existing products or new development, CFD simulations)Engineering | – | – | – | – | – |
| Cannula development for EKZ and ECMO (hydraulic design/characterization)Engineering | – | – | – | – | – |
| Test rig construction (test method development, conception, assembly, CE certification,Testing | – | – | – | – | – |
| Sustained pressure test rig for catheter testing (1–7 lumens)Testing | – | – | – | – | – |
| High-pressure test rig for catheter testing according to DIN EN ISO 10555-1 (burst testing and flowTesting | – | – | – | – | – |
| Test rig for in-process inspection (laser-based metrology)Testing | – | – | – | – | – |
| Metrology and process technology (development of manual and (semi-)automated processes,Testing | – | – | – | – | – |
| Measurement of the strength of adhesive bondsTesting | – | – | – | – | Nitinol |
| Prototype and jig/fixture construction (feasibility studies, functional prototypes, hand samples,Engineering | – | – | – | – | – |
| Manufacture of components using conventional manufacturing methodsEngineering | – | – | – | – | – |
| SLA 3D printing (prototypes)Additive | – | – | – | – | biocompatible materials |
| Dip coating (laboratory system, deposition of a plastic from solvent)Plastics | – | – | – | – | – |
| Assembly process development (optimization of manual assembly tasks up to statistical monitoring inAssembly | – | – | – | – | – |
| Production transfer (training on manufacturing and product documents, jig/fixture production)Engineering | – | – | – | – | – |
| Production potential analysis (value stream analysis)Engineering | – | – | – | – | – |
6 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Hydraulics laboratory (laboratory equipment) | – | – | – | – | Würselen |
| Dip-coating laboratory system | – | 1 | – | – | Würselen |
| Linear axis | – | 1 | – | – | Würselen |
| Rotary axis | – | 2 | – | – | Würselen |
| Sustained pressure test rig | evos | 1 | – | – | Würselen |
| High-pressure test rig (35 bar) | evos | 1 | – | – | Würselen |
Additional services
Quality and standards
Development processes and documentation are modeled on ISO 13485 and the MDR. Test rigs are delivered including CE certification, commissioning and qualification according to DQ/IQ/OQ/PQ; the metrology and process technology includes qualification according to OQ/PQ.
| Evidence | Würselen |
|---|---|
| Development and documentation modeled on ISO 13485 and the MDR | |
| CE certification of test rigs | |
| Qualification DQ/IQ/OQ/PQ | |
| Catheter testing according to DIN EN ISO 10555-1 |