Certifications and Quality at I-ME
Equipment Certifications
All equipment distributed by I-ME holds current international certifications:
- CE (Conformité Européenne): Compliance with European Union safety directives
- FDA (Food and Drug Administration): Approval by the US regulatory agency
- INVIMA (National Institute for Drug and Food Surveillance): Colombian health registry
Without INVIMA registration, a medical device cannot be legally sold or used in healthcare institutions in Colombia.
What Do These Certifications Guarantee?
- Verified clinical safety for patient use
- Demonstrated efficacy per international standards
- Lot and serial traceability for after-sales support
- Regulatory compliance for institutional audits (accreditation)
After-Sales Support and Warranty
- Factory warranty included with each device
- Preventive and corrective technical support by certified engineers
- Availability of original spare parts and consumables
- Metrological calibration and verification
Technical Service Coverage
Certified technical engineers in all 32 departments of Colombia.
Contact to Verify Specific Certifications
To check the INVIMA registration number or any other certification for a specific device, contact us via WhatsApp +57 313 867 4059 or info@i-me.com.co