Legal notice:
The certificates are intended for informational use by qualified professionals. Any redistribution, alteration, or publication without written approval is prohibited.

Certificates for Our Medical Devices
Access the valid and current certificates for our medical devices below.
All documents are provided as accessible PDF files and comply with MDR/ IVDR and EN ISO 13485 requirements.
bsi – Certificate of Registration
bsi – EU Quality Management System Certificate

Got questions? Let’s talk!
Whether you’re exploring EU market access or ready to start your project – we’re here to help.
Let’s connect and find the right solution for your medical device.
