Development, production and distribution of medical technology products – from idea to market launch.
amedtec GmbH — Austrian Medical Technologies
Kühnsdorf (AT)New on Amplifa
About amedtec
amedtec GmbH (Austrian Medical Technologies), based in Kühnsdorf, Carinthia, is a company specialized in medical technology that accompanies products along the entire life cycle: from ideation and the concept phase through research and pre-development, product development, verification and validation, to regulatory affairs and approval, industrialization and production, as well as market launch and distribution. The focus is on innovative support systems and precision measurement technology for healthcare. The approach combines clinical expertise, engineering and regulatory know-how: in close collaboration with physicians and clinics, the company identifies real needs and translates them into functional, safe and economically viable products. The range of services includes risk analyses in accordance with ISO 14971, usability engineering, quality management according to ISO 13485 as well as MDR and CE approval procedures. Reference projects include the development of a novel heated tube system.
- Site
- Kühnsdorf
- Processes
- Medical Technology Product Development (Ideation & Concept Phase, Research & Pre-Development,, Prototype Construction, Transfer to Series Production / Setup of Production Processes / Scaling of Manufacturing, Quality Assurance in Production, Production and Distribution of Medical Products (incl. Measurement Technology for Healthcare), Ideation & Concept Phase, Research & Pre-Development, Product Development
- Materials
- Usability Engineering (Human Factors), Risk Management according to ISO 14971, Quality Management according to ISO 13485, MDR Procedures & CE Marking
- Certificates
- ISO 13485 (Quality Management), Risk analyses according to ISO 14971, MDR / CE approval
- Industries
- Medical Technology, Healthcare, Clinics
- 01
Ideation & Concept Phase
- 02
Research & Pre-Development
- 03
Product Development
- 04
Verification & Validation
- 05
Regulatory Affairs & Approval
- 06
Industrialization & Production
- 07
Market Launch & Distribution
Processes & Methods
Usability Engineering (Human Factors)
Integration of user requirements into the development and validation of medical products.
Risk Management according to ISO 14971
Systematic risk analyses in research and pre-development.
Quality Management according to ISO 13485
Establishment and assurance of quality management for approval.
MDR Procedures & CE Marking
Preparation of technical documentation and support of approval procedures.
Site
Kühnsdorf
ATHead Office / Site
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Medical Technology Product Development (Ideation & Concept Phase, Research & Pre-Development,Engineering | – | – | – | – | – |
| Prototype ConstructionEngineering | – | – | – | – | – |
| Transfer to Series Production / Setup of Production Processes / Scaling of ManufacturingAssembly | – | – | – | – | – |
| Quality Assurance in ProductionTesting | – | – | – | – | – |
| Production and Distribution of Medical Products (incl. Measurement Technology for Healthcare)Assembly | – | – | – | – | – |
Additional services
Quality & Regulatory Affairs
Quality assurance takes place along the product life cycle phases – from verification and validation to risk analyses according to ISO 14971 to quality assurance in production as well as quality management according to ISO 13485.
| Evidence | Kühnsdorf |
|---|---|
| ISO 13485 (Quality Management) | |
| Risk analyses according to ISO 14971 | |
| MDR / CE approval |