Therapeutic apparatus

Medical devices comprise a wide range of products ranging from simple products, such as bandages, to complex devices, such as proton irradiation installations. Our test station is focused mainly on the testing and assessment of electrical medical devices, but we are also able to assess and test a great variety of mechanical devices. Accredited output documents from our test station may be used as a basis for the conformity demonstration procedure in accordance with Government Regulation 336/2004 Coll., and Directive 93/42/EEC.

What is tested?

• Mechanical safety
• Mechanical strength
• Stability
• Handles and other means for handling
• Moving parts
• Support systems
• ...

What is assessed

• Accompanying documentation
• Instructions
• Technical description
• Certificates or declarations of conformity of the components used
• Marking
• Structure
• Risk management
• Usability