Why certifications matter
Certifications determine whether your equipment can be legally installed, used, and serviced in your country. They also signal the manufacturer’s quality system maturity.
CE marking (EU)
Mandatory for most equipment sold in the EU. Issued by the manufacturer, but reviewed by EU-based notified bodies for higher-risk classes.
FDA registration (US)
Class I devices only require registration; Class II/III need 510(k) clearance or PMA. Imported devices also need a US Agent.
ISO 13485 (Quality Management System)
The medical-device QMS standard. Required by EU and recommended globally for clinical lab equipment.
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