Medical technology is one of the most important growth sectors with enormous social impact. It sets the highest standards for safety, testing technology and expert knowledge for its products, systems and processes.
The VDE Institute offers the medical technology sector wide-ranging competence and valuable services – all at expert level and all from a single source. The advantages for our customers: guaranteed compliance with standards, confirmation of compliance with statutory requirements of the target countries, reliable usability, certified processes, from development to placing on the market, as well as international acceptance.
Competency platform medical technology
From tests and certification procedures to process evaluation and advice on standards
The services offered by the VDE Institute:
- equipment for determining and monitoring the vital parameters
- equipment for extracorporal circulation, infusions, haemopheresis
- respiratory, oxygen therapy and inhalation equipment
- surgical equipment and surgical aids
- equipment for imaging processes
- stimulation equipment
- radiotherapy equipment
- ophtalmological equipment
- dental equipment
- rehabilitation equipment, active protheses
- patient positioning and tansport equipment
Product safety including EMC, risk analysis/risk management
Material and environmental tests
Chemical product analysis
Usability test (assessment of ergonomic files)
Management assessment according to the medical device directive and certification of companies as “Notified Body”
Certificatiion
VDE, CE 0366, VDE-EMC. CB, DU-Certificate, UL, CSA