CE MEDICAL CERTIFICATE

Milesman Premium has the CE 0120 quality seal for medical devices, which certifies that they have been manufactured in compliance with the compulsory requirements outlined in the European directives..

These compulsory norms encompass different processes that must be carried out during the design and manufacture of the device, including:

Safety of the device

• Analysing and assessing all the risks
• Minimising side effects
• Ensuring bio-compatibility
• Ensuring electrical and mechanical safety
• Allowing or forbidding the device to be combined with other products
• Controlling the safety instructions and instructions for use in a comprehensive, detailed way

Use and benefits of the device

• Fulfilling the product properties specified
• Ensuring the results
• Preventing infection and contamination
• Clinically evaluating the devices
• Ensuring the precision of the measurements

Monitoring the device on the market

• Of the manufacturer
• Of the device during its entire life cycle.

The notified bodies – independent auditors and testing institutes – monitor and regularly audit the company to ensure that it complies with all the above.