Development and cleanroom production of medical plastic products for infusion, injection and transfusion technology
RoweMed AG – Medical 4 Life
Parchim · Melsungen (founding location, historic)New on Amplifa
About RoweMed AG
RoweMed AG – Medical 4 Life is a medium-sized medical technology company based in Parchim (Mecklenburg-Vorpommern) specializing in the development and production of medical plastic products. The focus is on complex customer-specific systems for the handling of sensitive medications as well as CE-certified catalog products for infusion, injection and transfusion technology. RoweMed realizes turnkey projects from the first sketch through CAD design (SolidWorks) and rapid prototyping to the approved series product, including complete technical documentation in accordance with the MDR. In certified cleanrooms (ISO 7 and ISO 8), injection molding, blow molding, assembly and packaging are offered from a single source – from one-off production to automated large-scale series. All common welding and bonding technologies as well as validated sterilization processes (ethylene oxide, gamma irradiation, autoclaving) are used. Customers come from medical technology, pharma and biotech, and delivery is worldwide.
- Site
- Parchim
- Processes
- Injection molding (ISO 8 cleanroom), Blow molding (ISO 8 cleanroom), Assembly (manual to fully automated, ISO 7 cleanroom), Packaging of medical devices (ISO 7 cleanroom), Solvent bonding, UV bonding, Ultrasonic welding, Thermal welding
- Materials
- Plastics, Injection Molding (ISO 8 Cleanroom), Blow Molding (ISO 8 Cleanroom), Assembly (ISO 7 Cleanroom), Solvent bonding, UV bonding, ultrasonic, thermal and circular welding, Sterilization, CAD Design (SolidWorks) / Rapid Prototyping
- Certificates
- ISO 13485, EU MDR QMS Certificate (Regulation (EU) 2017/745, Annex IX), EU MDR QMS (Reg. (EU) 2017/745, Annex IX), ISO 9001
- Founded
- 2000
- Industries
- Medical technology, Pharmaceuticals, Biotech, Infusion, injection and transfusion technology
- 01
CAD design and rapid prototyping
- 02
Injection molding and blow molding (ISO 8 cleanroom)
- 03
Joining: welding and bonding technologies
- 04
Assembly (ISO 7 cleanroom)
- 05
Packaging of medical devices
- 06
Sterilization (ethylene oxide, gamma irradiation, autoclaving)
- 07
Regulatory affairs and technical documentation
Materials and Processes
Plastics
Used in cleanroom injection molding and blow molding for single-use fluid handling products.
Injection Molding (ISO 8 Cleanroom)
Precise manufacturing of complex plastic components from one-off production to automated large-scale series.
Blow Molding (ISO 8 Cleanroom)
Manufacture of hollow-chamber plastic parts for medical applications.
Assembly (ISO 7 Cleanroom)
Manual to fully automated assembly in four ISO 7 cleanrooms.
Solvent bonding, UV bonding, ultrasonic, thermal and circular welding
All common joining processes for medical plastic systems.
Sterilization
Validated processes: ethylene oxide, gamma irradiation, autoclaving.
CAD Design (SolidWorks) / Rapid Prototyping
Development from sketch to production-ready product with shortened time-to-market.
Locations
Parchim
DEDevelopment, cleanroom production (injection molding, assembly, packaging), administration
- Lot size
- One-off production to automated large-scale series
- Materials
- Plastics
- Injection molding machines
- Blow molding machines
- 4 ISO 7 cleanrooms (assembly, packaging)
- ISO 8 cleanroom (injection molding, blow molding)
Melsungen
DEFounding location (historic)
Components and Products
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Injection molding (ISO 8 cleanroom)Plastics | – | – | – | One-off production – automated large-scale series | Plastics |
| Blow molding (ISO 8 cleanroom)Plastics | – | – | – | – | Plastics |
| Assembly (manual to fully automated, ISO 7 cleanroom)Assembly | – | – | – | One-off production – Large-scale series | – |
| Packaging of medical devices (ISO 7 cleanroom)Assembly | – | – | – | – | – |
| Solvent bondingJoining | – | – | – | – | Plastics |
| UV bondingJoining | – | – | – | – | Plastics |
| Ultrasonic weldingJoining | – | – | – | – | Plastics |
| Thermal weldingJoining | – | – | – | – | Plastics |
| Circular weldingJoining | – | – | – | – | Plastics |
| Sterilization (ethylene oxide, gamma irradiation, autoclaving)Surface | – | – | – | – | – |
| CAD design (SolidWorks) / rapid prototypingEngineering | – | – | – | – | – |
| Optical and functional testing incl. incoming goods inspectionTesting | – | – | – | – | – |
Additional services
Quality and Certification
Quality assurance includes optical and functional testing of manufactured individual parts and assemblies according to test specifications as well as incoming goods inspections with complete documentation. The quality management system is certified to ISO 13485 and accredited with an EU MDR QMS certificate (DNV MEDCERT, Notified Body 0482) for the design, production and final inspection of medical devices of Classes Is and IIa.
| Evidence | Parchim |
|---|---|
| ISO 13485 | |
| EU MDR QMS (Reg. (EU) 2017/745, Annex IX) | |
| ISO 9001 |
History
- 2000
Founded in Melsungen as a pure development company in the field of medical technology with 5 engineers; innovative specialty products for infusion technology
- 2004
Relocation to Parchim; massive expansion of development capacity and establishment of a certified cleanroom production facility
Continuous investment in production technology and capacity expansion; today active worldwide as a developer and manufacturer of medical specialty products